Single-center Randomized Study Research Articles

Comparison of the effectiveness of supportive chemotherapy for patients with acute myeloid leukemia

Introduction. Achieving complete remission and prolonging event-free survival is the primary task of chemotherapeutic treatment for patients with acute myeloid leukemia (AML). Supportive therapy is a possible way to maintain complete remission.Aim: to compare two variants of supportive treatment (5+5 and 6-MP + Mtx) in patients with AML in the first complete remission after completion of the induction and consolidation programs.Materials and methods. The single-center randomized study included 34 AML patients treated from 2017 to 2021. The median age was 36 (18–56) years, the ratio of men to women was 18:16. After completing the induction and consolidation program, randomization was performed for different branches of supportive chemotherapy: 5+5 (cytarabine 50 mg/m2 2 times/day, mercaptopurine 60 mg/m2 days 1–5, a total of 6 courses) — first group (18 patients), and 6-MR + Mtx (6-mercaptopurine 50 mg/m2 daily, methotrexate 15 mg/m2 once/week) — second (16 patients). Courses of maintenance therapy were conducted until the total completion of treatment, the implementation of allogenic hematopoietic stem cell transplantation (allo-HSCT), the development of relapse, or death of the patient.Results. The two-year overall survival in the 5+5 group was 93 %, in 6-MP + Mtx group 68 % (p = 0.0814). Mortality in both groups was associated with complications in the post-transplant period. The actual OS and the hypothetical one — without performing allo-HSCT, did not differ. Thus, the fact of performing allo-HSCT does not affect the effectiveness of maintenance therapy courses. The two-year disease-free survival rate (DFS) was 66 % in the 5+5 group and 63 % in the 6-MP + Mtx group (p = 0.42). From the time of randomization, 8 patients (24 %) have relapsed and 1 patient died from complications after allo-HSCT.Conclusion. During treatment under the maintenance therapy programs 5+5 and 6-MP+Mtx, similar OS and RFS were achieved. During 5+5 program, hospitalization in a day hospital is required. The 6-MP+Mtx program has similar effectiveness, however, the entire period of supportive treatment can be carried out on an outpatient basis but lasts 24 months compared to 6 months when using the 5+5 program. The choice of maintenance therapy according to the 5+5 program is optimal from the point of view of the quality of life of patients.

Features of the oropharyngeal microbiota of healthy children and those with acute respiratory infections. A prospective single-center randomized study

Background. The oropharyngeal microbiota is involved in the development of colonization resistance, affecting viral adhesion and metabolism. Any deviations in the stability of the environmental microbial niches of the oropharynx alter the local immune response and can trigger severe chronic somatic disorders. Aim. To compare the composition of the microbiota of children during an episode of respiratory infection and healthy volunteers examined in different periods of convalescence. The obtained data can be used to predict the course of the disease, analyze the risk of complications, and assess the frequency of the diseases in the future. Materials and methods. From 20.01.2022 to 23.12.2022, an open-label prospective single-center randomized comparative study was conducted, which included 120 children aged 5-10 who presented with symptoms of acute respiratory infection. The control group consisted of 15 asymptomatic children examined at different periods of convalescence. The study compared changes in the oral microbiota composition of patients and healthy children. The evaluation was performed using complete 16S rRNA gene sequencing on the Oxford Nanopore platform. Taxonometric analysis at the species and genera level was performed using the Knomics-Biota platform. The R programming language was used for statistical processing. In addition, the parameters of α- and β-diversity of the microbiota were assessed. The Chao1 and Shannon indices were calculated to assess α-diversity (diversity within one community). The Chao1 index is based on the number of species found in the sample and also rare species that are found only 1 or 2 times, thus preventing underestimation of diversity. The Shannon index includes both the number of species and their uniformity in the community. A change in the index indicates the dominance of one or more species. The following indicators were used to assess the β-diversity describing the differences between two microbiota samples at the species and genera level: Bray–Curtis dissimilarity (characterizing the ratios of common and different microorganisms between the samples) and the Aitchison distance (reflecting the differences in the proportions of microorganisms). In addition, the balance between the two groups of microorganisms was evaluated using the NearesBalance method, which characterizes the differences between the microbiota of the main and control groups. Results. The results of our study show that during respiratory infection, the state of the oropharyngeal microbiota is characterized by an increase in α-diversity, which is associated with an increase in the proportion of species of Streptococcus salivarius, Streptococcus pneumoniae, Streptococcus pseudopneumoniae, Streptococcus pyogenes, Streptococcus thermophilus and A12 versus the proportion of Streptococcus mitis, Streptococcus oralis, Streptococcus gwangjuense, Streptococcus sanguinis, Streptococcus gordonii and FDAARGOS_192. In the control group, the oropharyngeal microbiota was divided into two clusters. The dominance of streptococci was observed in the first group (control), while the second group had a more uniform representation. Analysis of the changes in microbial communities in the main and control groups can show the stages of oral microbiota recovery after an acute respiratory infection episode. Conclusion. More research is needed in the field of the oropharyngeal microbiome on a larger sample of healthy children, to standardize the communities of the oropharyngeal microbiota, to study the interaction within communities and with the body as a whole. Analysis of the impact of the microbiota on the frequency and course of respiratory infections and the rate of complications opens up new prospects in treating, rehabilitating, and preventing diseases. These research areas can contribute to improving children's health and quality of life and introducing new approaches into clinical practice.

The safety and efficacy of stapler method for transection of the pancreatic parenchyma during pancreatoduodenectomy (STRAP-PD trial): study protocol for a randomized control trial.

Pancreaticoduodenectomy is a highly difficult and invasive type of gastrointestinal surgery. Prevention of postoperative pancreatic fistula is important, and this may be possible by the stapler method. STRAP-PD is a single center randomized controlled trial. We compare a method of transecting the pancreatic parenchyma in pancreaticoduodenectomy using a surgical stapler device with a conventional transecting method using energy devices (e.g., scalpel, ultrasonic coagulator and incision devices). Patients with soft pancreas who are scheduled to undergo pancreaticoduodenectomy are randomized to arm A (conventional method) or arm B (stapler method). We aim to examine the safety and usefulness of dissection by the automatic suture device, with attention to the rate of pancreatic fistula ISGPF grade B or C and to postoperative complications. This is a single-center randomized study, which began in September 2023 at Wakayama Medical University Hospital. Pancreatic parenchymal transection is typically performed either by direct incision using a scalpel or by employing energy devices such as ultrasonic coagulating cutting devices during pancreaticoduodenectomy. In a prospective pilot study, we conducted pancreatic parenchymal transection in 20 consecutive normal pancreatic cases during pancreaticoduodenectomy, observing postoperative pancreatic fistula grade B in one case (5%). Traditional methods involving scalpel incision or the use of ultrasonic coagulating cutting devices have been historically favored but perceived as technically challenging, and they have been reliant upon the surgeon's skill. Notably, relatively high incidences of postoperative pancreatic fistula among patients with soft pancreas have also been observed. Our proposed stapler method may therefore be a useful method responsible for reducing the development of pancreatic fistula. This method would be as part of minimally-invasive surgery for pancreaticoduodenectomy. It uses an endoscopic linear stapler to cut the pancreatic parenchyma, so it is likely to be more convenient than conventional methods and can be used universally. TRIALREGISTRATION: University Hospital Medical Information Network Clinical Trials Registry,UMIN000052089. the Registration Date on 1st September 2023.

Efficacy of subperiosteal drains in chronic subdural hematoma: a prospective randomized single-center study.

Background Chronic subdural hematomas (cSDH) are most frequently treated by evacuation via a burr-hole craniostomy procedure. Subperiosteal drains have been introduced as alternatives to subdural ones but only a few prospective studies have explored their efficacy. Thus, a prospective randomized trial was designed to assess their use. Methods The study enrolled patients with newly diagnosed surgically amenable cSDH. These patients were randomized into two groups. The first group underwent cSDH evacuation via a single burr-hole craniostomy procedure followed by placement of a subperiosteal drain; the second group underwent the identical procedure without drain placement. Patient demographics, drain volumes, duration of drainage, cSDH recurrence, and postoperative outcomes were recorded. Results Eighty-eight patients presenting with cSDH (12 with bilateral findings) from a total of 100 surgical cases were enrolled. Nine patients (1 bilateral) were lost to follow-up. Of all remaining 90 procedures, 37 were carried out with drain placement and the remaining 53 without. There were 5 recurrent cases (13,5%) in the drain group and 17 (32,1%) in the control group without drain placement. This resulted in a statistical significance (OR 0.33; p<0.05) favoring the use of a drain. Conclusion Subperiosteal drain placement can be used safely and effectively to treat cSDH in conjunction with a burr-hole craniostomy procedure, significantly reducing the rate of recurrence without any additional disadvantages.

Radial artery catheterization using a novel T-type ultrasound probe: a single-center randomized study.

Ultrasound guidance has been reported to facilitate radial artery catheterization compared with the palpation method. However, a recent meta-analysis showed that there was not significant differences in the first attempt success rate between the long-axis in-plane (LA-IP) method and the short-axis out-of-plane method. In 2023, we started using a novel T-type probe. We can recognize the needle first during the radial artery access with the short-axis view and then dose it with the long-axis view using the T-type probe. Therefore, we hypothesized that the T-type probe-guided method might heighten the first attempt success rate in radial artery catheterization, even for non-expert practitioners, compared with the LA-IP technique. One hundred and fifty adult patients, older than 20years, ASA I to III, were randomly assigned to the T-type probe-guided group (Group T: n = 75) or the LA-IP group (Group L: n = 75). The primary outcome was the first attempt success rate. The first attempt success rate in Group T (49/71, 69%) was significantly higher than that in Group L (31/68, 46%) (p = 0.0062). The present study showed that the T-type probe might facilitate the radial artery catheterization rather than the LA-IP method.

Cognitive aid and performance for simulated umbilical venous catheter placement: A randomized trial

IntroductionNeonatal resuscitation may require urgent umbilical venous catheter (UVC) placement. Complications can be observed with umbilical venous catheterization, especially in a stressful context. Inspired by the aeronautic environment, medical routine checklists, also called “cognitive aids,” secure the equipment and environment for the patients once they are admitted to the operating room. We hypothesized that reading a cognitive aid for UVC placement in the delivery room during neonatal resuscitation simulation scenarios can (a) improve the performance in reducing catheterization duration and (b) can limit complications. MethodsThis was a prospective single-center randomized study. A total of 23 dyads for a simulation scenario were included: 12 in the control group and 11 in the cognitive aid group. In the cognitive aid group, the cognitive aid was read by the same facilitator for every scenario. ResultsNo significant difference concerning the duration of the procedure was identified between the cognitive aid and control groups: 412 s [342; 420] vs. 374 s [338;402], respectively (p = 0.781). Nevertheless, there were significantly fewer deviations from hygiene guidelines and improved prevention of air embolism in the cognitive aid group compared with the control group. ConclusionThe UVC insertion time was similar between the control and cognitive aid groups. Moreover, cognitive aid can limit infectious complications or air embolism by allowing caregivers to follow UVC placement standards.

Impact of extended lung protection during mechanical ventilation on lung recovery in patients with COVID-19 ARDS: a phase II randomized controlled trial

BackgroundProtective ventilation seems crucial during early Acute Respiratory Distress Syndrome (ARDS), but the optimal duration of lung protection remains undefined. High driving pressures (ΔP) and excessive patient ventilatory drive may hinder lung recovery, resulting in self-inflicted lung injury. The hidden nature of the ΔP generated by patient effort complicates the situation further. Our study aimed to assess the feasibility of an extended lung protection strategy that includes a stepwise protocol to control the patient ventilatory drive, assessing its impact on lung recovery.MethodsWe conducted a single-center randomized study on patients with moderate/severe COVID-19-ARDS with low respiratory system compliance (CRS < 0.6 (mL/Kg)/cmH2O). The intervention group received a ventilation strategy guided by Electrical Impedance Tomography aimed at minimizing ΔP and patient ventilatory drive. The control group received the ARDSNet low-PEEP strategy. The primary outcome was the modified lung injury score (mLIS), a composite measure that integrated daily measurements of CRS, along with oxygen requirements, oxygenation, and X-rays up to day 28. The mLIS score was also hierarchically adjusted for survival and extubation rates.ResultsThe study ended prematurely after three consecutive months without patient enrollment, attributed to the pandemic subsiding. The intention-to-treat analysis included 76 patients, with 37 randomized to the intervention group. The average mLIS score up to 28 days was not different between groups (P = 0.95, primary outcome). However, the intervention group showed a faster improvement in the mLIS (1.4 vs. 7.2 days to reach 63% of maximum improvement; P < 0.001), driven by oxygenation and sustained improvement of X-ray (P = 0.001). The intervention group demonstrated a sustained increase in CRS up to day 28 (P = 0.009) and also experienced a shorter time from randomization to room-air breathing (P = 0.02). Survival at 28 days and time until liberation from the ventilator were not different between groups.ConclusionsThe implementation of an individualized PEEP strategy alongside extended lung protection appears viable. Promising secondary outcomes suggested a faster lung recovery, endorsing further examination of this strategy in a larger trial.Clinical trial registration This trial was registered with ClinicalTrials.gov (number NCT04497454) on August 04, 2020.

Late video-assisted thoracoscopic surgery versus thoracostomy tube reinsertion for retained hemothorax after penetrating trauma, a prospective randomized control study.

Early video-assisted thoracoscopic surgery (VATS) is the recommended treatment of choice for retained hemothorax (RH). A prospective single-center randomized control study was conducted to compare outcomes between VATS and thoracostomy tube (TT) reinsertion for patients with RH after penetrating trauma in a resource constrained unit. Our hypothesis was that patients with a RH receiving VATS instead of TT reinsertion would have a shorter hospital stay and lesser complications. From January 2014 to November 2019, stable patients with thoracic penetrating trauma complicated with retained hemothoraces were randomized to either VATS or TT reinsertion. The outcomes were length of hospital stay (LOS) and complications. Out of the 77 patients assessed for eligibility, 65 patients were randomized and 62 analyzed: 30 in the VATS arm and 32 in the TT reinsertion arm. Demographics and mechanisms of injury were comparable between the two arms. Length of hospital stay was: preprocedure: VATS 6.8 (+/-2.8) days and TT 6.6 (+/- 2.4) days (p=0.932) and postprocedure: VATS 5.1 (+/-2.3) days, TT 7.1 (+/-6.3) days (p=0.459), total LOS VATS 12 (+/- 3.9) days, and TT 14.4 (+/-7) days (p=0.224). The TT arm had 15 complications compared to the VATS arm of four (p=0.004). There were two additional procedures in the VATS arm and 10 in the TT arm (p=0.014). VATS proved to be the better treatment modality for RH with fewer complications and less need of additional procedures, while the LOS between the two groups was not statistically different.

Evaluation of the effectiveness and safety of erector spinae plane block during coronary artery bypass surgery: a randomized clinical trial

The search for a method of perioperative pain control after coronary bypass surgery is relevant both from the point of view of safety and effectiveness of the methods used.Aim: To evaluate the hemodynamic changes and effectiveness of erector spinae plane block (ESPB) for off-pump coronary artery bypass surgery.Methodology and research methods. The prospective randomized single-center study included 45 patients equally distributed according to the applied methods of perioperative analgesia into 3 groups: general anesthesia with epidural anesthesia (GA + EA group, n = 15), general anesthesia with ESPB (GA + ESPB group, n = 15) and general anesthesia without any regional anesthesia techniques (GA group, n = 15). Assessment of hemodynamics and severity of pain syndrome was performed during the first postoperative day.Results. The intraoperative dose of fentanyl was 0.4 (0.4–0.5) mg in the GA + EA group, and 0.4 (0.3–0.4) mg in the GA + ESPB group that is significantly less than in the GA group – 1.1 (1.0–1.1) mg (p &lt; 0.001). Postoperatively, the dose of fentanyl was 0.10±0.04 mg in the GA + EA group and 0.23±0.05 mg in the GA group (p &lt; 0.001), whereas in the ESPB group fentanyl was not used. The pain level assessed by the numeric rating scale (NRS) was 3.0 (2.0–4.0) points at one hour after tracheal extubation and 3.0 (0.5–3.5) points at the end of the first day of the postoperative period without difference between the groups. The systemic and pulmonary hemodynamics, respiratory and vasopressor support did not differ as well.Conclusion. The use of regional anesthesia (EA and ESPB) provides similar quality of perioperative analgesia like general anesthesia, but leads to reduction in opioid doses. Postoperatively, the use of ESPB does not lead to a deterioration of the hemodynamic status of the patient.

Evaluation of clinical effectiveness of hygiene products for the care of facial prostheses

BACKGROUND: Because of the porous structure of the structural material used in the production of facial prostheses, without careful hygienic care, microbial biofilms may form on the material surface, its color and shape may change, and premature aging may occur. Means for the hygienic care of facial prostheses and research to confirm their clinical effectiveness are crucial in dentistry.&#x0D; AIM: To increase the effectiveness of the hygienic treatment of facial epitheses.&#x0D; METHODS: A single-center randomized study was conducted to assess the clinical effectiveness of hygiene products for the care of facial prostheses. This study involved patients with exenteration of the eye socket, previously prosthetic with adhesive fixation epitheses. The patients were divided into four groups and received different hygienic care methods. Furthermore, during the use of the prosthesis for 14 days and 1 and 3 months, the tissues of the prosthetic bed and hygienic condition of the prosthesis were evaluated, and the quality of life of patients was determined.&#x0D; RESULTS: According to the results of measuring the area of inflammation of tissues of the prosthetic bed of the eye socket at different terms, positive dynamics were found in the groups that used the proposed hygiene products.&#x0D; CONCLUSION: A strong positive correlation (r 0.9) of the average values of the quality of life index, area of inflammation, and hygiene index of the orbital epitheses in the study groups at the appropriate time indicates improved quality of life of patients who used the proposed hygiene products by reducing the amount of bacterial plaque on the surface of the epithesis and, in turn, reducing the area of inflammatory reactions and increasing comfort in wearing the prosthesis.

Patient satisfaction with coronary CT angiography versus invasive coronary angiography: results of a single-center randomized trial

ObjectiveBecause there is evidence for a clinical benefit of using coronary computed tomography (CT) angiography instead of invasive coronary angiography (ICA) in patients with suspected coronary artery disease (CAD), we ascertained if patient satisfaction could represent an important barrier to implementation of coronary CT in clinical practice.Materials and methodsA total of 329 patients with suspected CAD and clinical indication for ICA were randomly assigned to undergo either CT or ICA for guiding treatment. Satisfaction for both groups was assessed by patient questionnaire completed twice, ≥24 h after CT or ICA, and at follow-up after a median of 3.7 years. Assessment included preparation, concern, comfort, helplessness, pain, willingness to undergo tests again, overall satisfaction, and preference. Pearson’s chi-square test and Wilcoxon rank-sum test were used.ResultsOverall, 91% of patients undergoing CT (152/167) and 86% undergoing ICA completed assessment (140/162, p = 0.19). Patients reported being significantly better prepared for CT, less concerned about the test, and felt less helpless than during ICA (all: p < 0.001). Subjective pain (horizontal nonmarked visual analogue scale) was significantly lower for CT (6.9 ± 14.7) than for ICA (17.1 ± 22.7; p < 0.001). At follow-up, significantly more patients in the CT group reported very good satisfaction with communication of findings compared with the ICA group (p < 0.001) and 92% would recommend the institution to someone referred for the same examination.ConclusionsResults from our single-center randomized study show very good satisfaction with coronary CT compared to ICA. Thus, superior acceptance of CT should be considered in shared decision-making.Clinical relevance statementThis evaluation of patient satisfaction in a randomized study shows that patients’ preference is in line with the clinical benefit provided by CT and also suggests to prefer a CT-first strategy in suspected coronary artery disease.Key Points• Subjective pain was significantly lower for coronary CT angiography than for invasive coronary angiography and patients felt better prepared and less concerned about CT.• Patients were overall more satisfied with coronary CT angiography than invasive coronary angiography in a randomized controlled trial.• After a median follow-up of 3.7 years, more patients in the CT group indicated very good satisfaction with the communication of findings and with the examination itself.

Results of a cohort single-center randomized study of the modulating effect of the drug Mexidol in the rehabilitation of patients who suffered acute cerebral insufficiency

Evaluation of the effect of pharmacological modulation of the rehabilitation process with the drug mexidol as an adjuvant component of the rehabilitation treatment of cognitive-emotional disorders in patients who have suffered acute cerebral insufficiency (ACI) due to acute cerebrovascular accident or traumatic brain injury. The study was conducted as a randomized interventional prospective study and consisted of 5 visits. Patients were divided into 2 groups: main (n=30, standard therapy + Mexidol IV 500 mg per day for 10 days, followed by Mexidol FORTE 250 orally, 1 tablet 3 times a day for 8 weeks) and control (n=30, standard therapy for 66 days). The study randomized 60 patients who underwent ACN and received rehabilitation treatment in accordance with regional routing. In the main group, there was an improvement in cognitive functions comparable to the control group (p<0.001, in both groups there was an improvement in the Schulte test «work efficiency» and «total execution time», according to the MoCA scale (visit 5 - 23.8±2.6 vs 22.9±31, p=0.227). A significant superiority of the main group over the control group was shown in such indicators as a decrease in anxiety (according to the HADS scale) (visit 4 - 2.6±2.4 vs 4.4±2.4, p=0.004), a decrease in the severity of depression (according to the Beck scale) (visit 3 - 7.5±4.5 vs 11.4±5.6, p=0.005). There was a tendency for the main group to be superior in terms of muscle strength (according to the MRC scale (visit 4 - 3.3±5.1 vs 2.1±2.2, p=0.051), level of vital activity (according to the ShRM - visit 5 - 2.9±0.7 vs 3.3±0.6, p=0.053). A statistically significant increase in the level of mobility of patients in the group using the drug Mexidol was proven compared to the control group (the difference in the Rivermead index at the 5th visit was 10.3±2.8 and 8.0±2.8, respectively, p=0.006), the average increase in the Rivermead index by visit 5 (5.4±2.1 vs 3.4±1.6, p<0.001). A decrease in intensive care aftereffects syndrome (ITS) scores was detected in both groups; a statistically significant decrease in the severity of ITS in relation to the previous visit was detected only in the group using the drug Mexidol (p<0.001). In the main group, the best indicators of the dynamics of systolic cerebral blood flow velocity and overshoot coefficient were also determined, compared to the control group. There were no adverse events recorded in the study. A positive modulating effect of Mexidol has been demonstrated in terms of accelerating the restoration of tolerance to cognitive loads, improving the psycho-emotional background by reducing symptoms of anxiety and depression, and secondary improving the results of motor rehabilitation in the early recovery period in patients who have undergone ACI, including those with manifestations of PIT syndrome. During the study, no adverse events were recorded, as well as significant differences in vital functions in the study groups, which indicates comparable safety of therapy in the control and main groups.

СТРАТИФИКАЦИОННЫЙ ПОДХОД К ПРОФИЛАКТИКЕ РАЗВИТИЯ ФЕНОМЕНА НЕВОССТАНОВЛЕННОГО КОРОНАРНОГО КРОВОТОКА ПРИ ЭНДОВАСКУЛЯРНОМ ЛЕЧЕНИИ ПАЦИЕНТОВ С ИНФАРКТОМ МИОКАРДА С ПОДЪЁМОМ СЕГМЕНТА ST

Objective: To develop and test an algorithm for no-reflow phenomenon (NRP) prevention during endovascular treatment of patients with ST-elevation myocardial infarction (STEMI) Methods: A prospective single-center randomized study included 100 patients diagnosed with STEMI who underwent coronary artery stenting. Group 1 included 50 patients who were operated using an algorithm for the NRP prevention, while Group 2 included 50 patients who underwent routine transluminal balloon angioplasty and stenting of the coronary arteries. The NRP risk was assessed using the predictive model by Wang JW et al Results: Both groups were comparable in terms of anamnestic and clinical data, biochemical and instrumental examination results. High NRP risk was determined in 36% of Group 1 patients and 40% of Group 2 patients. NRP developed significantly less often in Group 1 patients compared to Group 2 (14% vs. 36%, p=0.01). Worsening of Killip class of acute heart failure was found significantly less common in Group 1 patients compared to Group 2 (2% versus 16%, p=0.03) Conclusion: The proposed algorithm for NRP prevention increased the effectiveness of treatment for STEMI Keywords: ST-elevation myocardial infarction, myocardial revascularization, percutaneous coronary intervention, no-reflow phenomenon.

The Efficacy of Budesonide, Levocabastine, and Their Combination in Treatment of Vasomotor Rhinitis

Introduction: Relevant studies have demonstrated that glucocorticoids and antihistamines, such as budesonide and azelastine, are effective in the treatment of vasomotor rhinitis, with their combined use being more effective than that of a single drug. The aim of this study was to assess the improvement in the symptoms of patients following the combined administration of these drugs. Methods: We conducted a single-center randomized study on 42 patients. Participants were randomly treated with budesonide, levocabastine hydrochloride, or their combination for 2 weeks. The visual analog scale (VAS) score and levels of eosinophil cationic protein (ECP), histamine (HA), leukotriene B4 (LTB4), and vasoactive intestinal peptide (VIP) in nasal secretions were evaluated before and after treatment. Results: The symptoms of patients were improved in all 3 treatment groups compared with those before treatment. Following combined treatment, the improvement in symptoms of nasal obstruction, runny nose, nasal itching, and sneezing was much greater than those in the groups treated with budesonide or levocabastine hydrochloride alone (p = 0.04, 0.004, 0.005, 0.004, respectively). The decreased levels of these inflammatory mediators were significantly different between the different treatment groups. Conclusions: Budesonide or levocabastine hydrochloride alone improved the nasal symptoms of patients with vasomotor rhinitis and reduced the levels of ECP, HA, LTB4, and VIP in nasal secretions. However, their combination improved the symptoms of patients more significantly than each drug alone.

Responsiveness to Infusion Load under Regional Anesthesia after Off-Pump Coronary Artery Bypass Graft Surgery

Objective. To evaluate the effect of erector spinae plane block (ESPB) and epidural anesthesia on responsiveness to infusion load after coronary bypass surgery on a beating heart.Materials and methods. A prospective randomized single-center study included 45 patients who were grouped into 3 equal arms based on anesthesia techniques: general anesthesia in combination with ESPB (GA+ESPB), general anesthesia and epidural anesthesia (GA+EA) and general anesthesia without regional techniques (GA). Patient’s response to volume loading was assessed using dynamic and orthostatic tests after transfer from the operating room and at the end of the first postoperative day. Passive leg raise (PLR) and standard bolus injection tests were done at the first stage; changes in hemodynamic parameters during verticalization were additionally evaluated at the second stage. Patients with 10% cardiac index (CI) increase after PLR test and 15% increase after bolus injection test were categorized as responders.Results. The concordance of obtained results in PLR and bolus injection tests for the GA+ESPB, GA+ EA and GA groups at the first stage was 0.53 (95% CI 0.12–0.94), 0.68 (95% CI 0.30–1.00) and 0.61 (CI 0.24–0.99), at the second stage — 0.70 (0.32–1.00), 0.84 (95% CI 0.55–1.00) and 0.82 (95% CI 0.47–1.00), respectively. There were no differences in distribution of responders between the groups. CI dynamics did not differ between the groups during verticalization, and there were no associations of CI changes during verticalization with the preceding PLR test results. The dynamics of troponin T and NT-proBNP did not differ between the groups.Conclusion. Methods of regional anesthesia (SPB or EA) do not significantly affect the responsiveness to infusion therapy in the postoperative period after coronary bypass surgery on a beating heart.

Standardized Treatment andDiagnostic Approach to Reduce Disease burden in the early postoperative phase in children with congenital heart defects—STANDARD study: a pilot randomized controlled trial

To explore the effect of a daily goal checklist on pediatric cardiac intensive care unit (PCICU) length of stay (LOS) after congenital heart surgery. This study is a prospective randomized single-center study. Group characteristics were as follows: STANDARD group: n = 30, 36.7% female, median age 0.9 years; control group: n = 33, 36.4% female, median age 1.1 years. Invasive ventilation time, STAT categories, mean vasoactive-inotropic score (VIS)24h, maximal (max.) VIS24h, mean VIS24–48h, max. VIS24–48h, VIS category, number of sedatives, analgesics, diuretics, number of deployed diagnostic modalities, morbidities, and mortality did not differ between both groups. Median PCICU LOS was 96.0 h (STANDARD group) versus 101.5 h (control group) (p = 0.63). In the overall cohort, univariate regression analysis identified age at surgery (b = −0.02), STAT category (b = 18.3), severity of CHD (b = 40.6), mean VIS24h (b = 3.5), max. VIS24h (b = 2.2), mean VIS24–48h (b = 6.5), and VIS category (b = 13.8) as significant parameters for prolonged PCICU LOS. In multivariate regression analysis, age at surgery (b = −0.2), severity of CHD (b = 44.0), and mean VIS24h (b = 6.7) were of significance. Within the STANDARD sub-group, univariate regression analysis determined STAT category (b = 32.3), severity of CHD (b = 70.0), mean VIS24h (b = 5.0), mean VIS24–48h (b = 5.9), number of defined goals (b = 2.6), number of achieved goals (b = 3.3), number of not achieved goals (b = 10.8), and number of unevaluated goals (b = 7.0) as significant parameters for prolonged PCICU LOS. Multivariate regression analysis identified the number of defined goals (b = 2.5) and the number of unevaluated goals (b = −3.0) to be significant parameters. Conclusion: The structured realization and recording of daily goals is of advantage in patients following pediatric cardiac surgery by reducing PCICU LOS.What is known:• Communication errors are the most frequent reasons for adverse events in intensive care unit patients.• Improved communication can be achieved by discussion and documentation of the patients’ goals during daily rounds.What is new:• In the overall cohort age at surgery, severity of congenital heart defect and mean vasoactive inotropic score within the first 24 hours had significant impact on pediatric cardiac intensive care unit (PCICU) length of stay (LOS).• In the intervention group, the number of defined goals and the number of unevaluated goals were significant parameters for prolonged PCICU LOS.

Comparison of dydrogesterone plus progesterone gel with subcutaneous aqueous progesterone plus progesterone gel for luteal phase supplementation of subsequent in vitro cycle in women after previous cycle failure.

The luteal phase supplementation (LPS) of the in vitro fertilization (IVF) cycle is crucial to increase the chance of a live birth. There is no preferred progestogen for use in the general population. The optimal progestogen regimen in the event of prior IVF failure is unknown. The aim was to compare the live birth rate for dydrogesterone plus progesterone gel versus aqueous progesterone plus progesterone gel in LPS of the IVF cycle in women with at least one previous IVF failure. A prospective randomized single-center study enrolled women with at least one previous IVF failure undergoing another IVF cycle. Women were randomly assigned in a 1:1 ratio to 2 arms depending on LPS protocol: dydrogesterone (Duphaston®) + progesterone in vaginal gel (Crinone®) vs aqueous progesterone solution in subcutaneous injection (Prolutex®) + progesterone in vaginal gel (Crinone®). All women underwent fresh embryo transfer. The live birth rate with one prior IVF failure was 26.9% for D + PG vs 21.2% for AP + PG (p = 0.54), and with at least two IVF failures: 16% for D + PG vs 31.1% for AP + PG (p = 0.16). There were no significant differences in live birth rates between protocols, regardless of the number of prior IVF failures. In light of the evidence from this study that neither of the two LPS protocols is more effective in women with prior IVF failure, other factors, such as potential side effects, dosing convenience and patient preference, should be considered when choosing a treatment.

Barbed versus conventional suture in laparoscopic myomectomy: A randomized controlled study.

To compare the surgical and clinical results of traditional absorbable polyglactin 910 and barbed sutures in laparoscopic myomectomy. This single-center randomized study included 75 women who underwent laparoscopic myomectomy. The uterine wall defects were closed with a continuous conventional absorbable polyglactin 910 suture (Vicryl; Ethicon, Somerville, NJ, USA) in 41 women and with a unidirectional barbed suture (V-Loc 180; Covidien, Mansfield, MA, USA) in 34 women. The time required to suture the uterine wall defect was lower in the V-Loc group than in the Vicryl group (p=0.007). However, no significant difference was observed in the operative time between the two study groups. The intraoperative blood loss and need for postoperative blood transfusion were significantly lower in the barbed group than in the Vicryl group (p=0.018 and p=0.048, respectively). In laparoscopic myomectomy cases, the unidirectional barbed suture is more effective than the conventional absorbable suture. Barbed sutures facilitate the suturing process and reduce the time required to suture the uterine wall defect, blood loss, and the need for postoperative blood transfusion.

Impact on the ability of healthcare professionals to correctly identify patient-ventilator asynchronies of the simultaneous visualization of estimated muscle pressure curves on the ventilator display: a randomized study (Pmus study)

BackgroundPatient-ventilator asynchronies are usually detected by visual inspection of ventilator waveforms but with low sensitivity, even when performed by experts in the field. Recently, estimation of the inspiratory muscle pressure (Pmus) waveforms through artificial intelligence algorithm has been proposed (Magnamed®, São Paulo, Brazil). We hypothesized that the display of these waveforms could help healthcare providers identify patient-ventilator asynchronies.MethodsA prospective single-center randomized study with parallel assignment was conducted to assess whether the display of the estimated Pmus waveform would improve the correct identification of asynchronies in simulated clinical scenarios. The primary outcome was the mean asynchrony detection rate (sensitivity). Physicians and respiratory therapists who work in intensive care units were randomized to control or intervention group. In both groups, participants analyzed pressure and flow waveforms of 49 different scenarios elaborated using the ASL-5000 lung simulator. In the intervention group the estimated Pmus waveform was displayed in addition to pressure and flow waveforms.ResultsA total of 98 participants were included, 49 per group. The sensitivity per participant in identifying asynchronies was significantly higher in the Pmus group (65.8 ± 16.2 vs. 52.94 ± 8.42, p < 0.001). This effect remained when stratifying asynchronies by type.ConclusionsWe showed that the display of the Pmus waveform improved the ability of healthcare professionals to recognize patient-ventilator asynchronies by visual inspection of ventilator tracings. These findings require clinical validation.Trial registration: ClinicalTrials.gov: NTC05144607. Retrospectively registered 3 December 2021.

High-Frequency versus Low-Frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia: Short-Term Results of a Randomized Trial

Introduction: The objective of the study is to determine if high-frequency (1 kHz) spinal cord stimulation (SCS) is better than low-frequency SCS for pain relief in chronic limb-threatening ischemia (CLTI). Methods: HEAL-SCS trial was designed as an open-label, parallel-group, single-center randomized study with a 1:1 allocation ratio. The trial was conducted in Meshalkin National Medical Research Center between August 2018 and February 2020. Total 56 patients underwent screening, 50 were enrolled, 6 were rejected. The participants were randomized into 2 cohorts of 25 patients each by an external coordinator using an online tool. A neurosurgeon and a vascular surgeon both examined all patients and estimated the pain intensity using visual analog scale (VAS), quality of life with short-form-36 health survey (SF-36), and functional status by walking impairment questionnaire (WIQ) at 3 and 12 months. Tissue perfusion was evaluated for 34 patients using transcutaneous oxygen tension measurement (TcPO₂) at baseline and in 12 months. Results: All 50 patients (84% men, median age 66.5 y.o) were available for primary outcome assessment 3 and 12 months after implantation. Intention-to-treat analysis demonstrated comparative advantage of HF-SCS over LF-SCS at 3 months with mean VAS score 2.8 (95% CI, 2.4; 3.2) and 3.3 (95% CI, 3.0; 3.6), respectively (p = 0.031). Clinical superiority of HF-SCS persisted at 12-month follow-up (p < 0.001). HF-SCS produced significantly greater pain relief by WIQ at 3 (p < 0.001) and 12 months (p = 0.009). Despite stair-climbing ability was better in HF-SCS group (p = 0.02), no significant difference between groups was found at 1-year post-op in terms of speed (p = 0.92) and distance scores (p = 0.68). Accordingly, the general and mental health domains of SF-36 were significantly better in HF-SCS at 12 months. Despite a tendency toward better resting oxygen pressure in HF-SCS group, there was no intergroup difference by TcPO₂ (p = 0.076). Only 1 patient (2%) required above-the-knee amputation at 10 months after LF-SCS implantation. Conclusion: High-frequency SCS provides better pain relief, life quality, and functional performance in patients with CLTI during short-term follow-up. The lack of perfusion difference between high-frequency and conventional SCS requires further examination to the possible long-term advantages of the method.