Prospective Randomized Crossover Trial Research Articles

Neurally adjusted ventilatory assist vs. pressure support to deliver protective mechanical ventilation in patients with acute respiratory distress syndrome: a randomized crossover trial

BackgroundProtective mechanical ventilation is recommended for patients with acute respiratory distress syndrome (ARDS), but it usually requires controlled ventilation and sedation. Using neurally adjusted ventilatory assist (NAVA) or pressure support ventilation (PSV) could have additional benefits, including the use of lower sedative doses, improved patient–ventilator interaction and shortened duration of mechanical ventilation. We designed a pilot study to assess the feasibility of keeping tidal volume (VT) at protective levels with NAVA and PSV in patients with ARDS.MethodsWe conducted a prospective randomized crossover trial in five ICUs from a university hospital in Brazil and included patients with ARDS transitioning from controlled ventilation to partial ventilatory support. NAVA and PSV were applied in random order, for 15 min each, followed by 3 h in NAVA. Flow, peak airway pressure (Paw) and electrical activity of the diaphragm (EAdi) were captured from the ventilator, and a software (Matlab, Mathworks, USA), automatically detected inspiratory efforts and calculated respiratory rate (RR) and VT. Asynchrony events detection was based on waveform analysis.ResultsWe randomized 20 patients, but the protocol was interrupted for five (25%) patients for whom we were unable to maintain VT below 6.5 mL/kg in PSV due to strong inspiratory efforts and for one patient for whom we could not detect EAdi signal. For the 14 patients who completed the protocol, VT was 5.8 ± 1.1 mL/kg for NAVA and 5.6 ± 1.0 mL/kg for PSV (p = 0.455) and there were no differences in RR (24 ± 7 for NAVA and 23 ± 7 for PSV, p = 0.661). Paw was greater in NAVA (21 ± 3 cmH2O) than in PSV (19 ± 3 cmH2O, p = 0.001). Most patients were under continuous sedation during the study. NAVA reduced triggering delay compared to PSV (p = 0.020) and the median asynchrony Index was 0.7% (0–2.7) in PSV and 0% (0–2.2) in NAVA (p = 0.6835).ConclusionsIt was feasible to keep VT in protective levels with NAVA and PSV for 75% of the patients. NAVA resulted in similar VT, RR and Paw compared to PSV. Our findings suggest that partial ventilatory assistance with NAVA and PSV is feasible as a protective ventilation strategy in selected ARDS patients under continuous sedation.Trial registration ClinicalTrials.gov (NCT01519258). Registered 26 January 2012, https://clinicaltrials.gov/ct2/show/NCT01519258

The effect of pre-cooling versus topical anesthesia on pain perception during palatal injections in children aged 7-9 years: a randomized split-mouth crossover clinical trial.

BackgroundTo compare pain perception during palatal injection administration in children aged 7–9 years while using pre-cooling of the injection site versus application of topical anesthesia as a pre-injection anesthetic during the six months.MethodsA prospective randomized split-mouth crossover trial was conducted among 30 children aged 7–9 years, who received topical application of either a pencil of ice (test group) or 5% lignocaine gel (control group) for 2 min before injection. The primary and secondary outcome measures were pain perception and child satisfaction, measured by the composite pain score and the faces rating scale, respectively. Unpaired t-test was performed to determine significant differences between groups.ResultsThe test group had significantly lower pain scores for self-report and behavioral measures (P < 0.0001). The changes in physiological parameters at the baseline (P = 0.74) during (P = 0.37) and after (P = 0.88) the injection prick were not statistically significant. Children felt better by the pre-cooling method (P < 0.0001).ConclusionIce application using a pencil of ice for 2 min reduced pain perception significantly compared to the use of a topical anesthetic. Moreover, ice application was preferred by children.

Citric-acid dialysate improves the calcification propensity of hemodialysis patients: A multicenter prospective randomized cross-over trial.

IntroductionThe concentration of dialysate calcium (dCa) has been suggested to affect vascular calcification, but evidence is scarce. Calcification propensity reflects the intrinsic capacity of serum to prevent calcium and phosphate to precipitate.The use of citric-acid dialysate may have a beneficial effect on the calcification propensity due to the chelating effect on calcium and magnesium. The aim of this study was to compare the intradialytic and short-term effects of haemodialysis with either standard acetic-acid dialysate with dCa1.50 (A1.5) or dCa1.25 (A1.25), as well as citric-acid dialysate with dCa1.50 (C1.5) in bicarbonate dialysis on the calcification propensity of serum.MethodsChronic stable hemodialysis patients were included. This multicenter randomized cross-over study consisted out of a baseline week (A1.5), followed by the randomized sequence of A1.25 or C1.5 for one week after which the alternate treatment was provided after a washout week with A1.5. Calcification propensity of serum was assessed by time-resolved nephelometry where the T50 reflects the transition time between formation of primary and secondary calciprotein particles.ResultsEighteen patients (median age 70 years) completed the study. Intradialytic change in T50 was increased with C1.5 (121 [90–152]min) compared to A1.25 (83 [43–108]min, p<0.001) and A1.5 (66 [18–102]min, p<0.001). During the treatment week, predialysis T50 increased significantly from the first to the third session with C1.5 (271 [234–291] to 280 [262–339]min, p = 0.002) and with A1.25 (274 [213–308] to 307 [256–337]min, p<0.001), but not with A1.5 (284 [235–346] to 300 [247–335]min, p = 0.33).ConclusionCalcification propensity, as measured by the change in T50, improved significantly during treatment in C1.5 compared to A1.25 and A1.5. Long-term studies are needed to investigate the effects of different dialysate compositions concentrations on vascular calcification and bone mineral disorders.

Marrow adipose tissue gradient is preserved through high protein diet and bed rest. A randomized crossover study

ContextMarrow adipose tissue (MAT) has a peripheral to central distribution in adults, higher in peripheral bones. Similarly, the spine has a caudal to cephalad MAT distribution, higher in lumbar vertebras. Diet and the level of physical activities are known modulators of MAT with significant impact on bone; however, whether these can modulate the MAT gradient is unknown. ObjectiveTo measure the effect of high protein diet and bed rest interventions on the lumbar MAT gradient. Design, participants, interventionIn a prospective randomized crossover trial, 10 healthy men participated in 2 consecutive campaigns of 21days head-down-tilt-bed-rest (HDTBR). They received either whey protein and potassium bicarbonate-supplemented or control diet separated by a 4-month washout period. Main outcome measure(s)Ten serial MRI measures of lumbar vertebral fat fraction (VFF) were performed at baseline, 10days and 20days of HDTBR and 3 and 28days after HDTBR of each bed rest campaign. ResultsThe mean L5-L1 VFF difference of 4.2±1.2 percentage point higher at L5 (p=0.008) constituted a caudal to cephalad lumbar MAT gradient. High protein diet did not alter the lumbar VFF differences during both HDTBR campaigns (all time points p>0.05). Similarly, 2 campaigns of 21days of HDTBR did not change the lumbar VFF differences (all time points p>0.05). ConclusionsThis pilot study established that the lumbar vertebral MAT gradient was not altered by a high protein nor by 2×21days bed rest interventions. These findings demonstrated that this lack of mechanical stimulus was not an important modulator of the lumbar MAT gradient. The highly preserved MAT gradient needs to be measured in more situations of health and disease and may potentially serve to detect pathological situations.

The renoprotective effect of concomitant fosfomycin in the treatment of pulmonary exacerbations in cystic fibrosis.

BackgroundFosfomycin, effective in Cystic Fibrosis (CF), competes with aminoglycosides at renal binding sites and may therefore afford a renoprotective effect when used in combination therapy. We explored this by using markers of acute renal tubular damage [N-acetyl-β-d-glucose-aminidase (NAG), alanine amino-peptidase (AAP) and β2-microglobulin].Methods Using a prospective randomized crossover trial design, at an acute pulmonary exacerbation, 18 adult CF patients received either 14 days of intravenous (IV) tobramycin or IV tobramycin and IV fosfomycin, both in combination with a second IV antibiotic (colomycin).Results Urinary NAG (P = 0.003) and AAP (P = 0.03) following treatment with concomitant fosfomycin were lower than those after treatment with tobramycin and colomycin alone. Fosfomycin attenuated the total 24-h urinary protein leak (P = 0.0001). The 14-day improvements in all surrogate markers of exacerbation resolution (FEV1% predicted, FVC, white cell count and C-reactive protein) were similar for both treatment regimens.Conclusion The addition of fosfomycin reduces acute renal injury caused by IV aminoglycoside therapy in CF pulmonary exacerbations.

The Effect of Graphic Organizers on Learning Outcomes, Study Efficiency, and Student Satisfaction in an Elective Veterinary Cardiology Course.

Graphic organizers (GOs) are visual and spatial displays, such as tables or charts, which facilitate learning by making conceptual relationships between content more apparent. We hypothesized that study aids in the form of GOs would lead to improved learning outcomes, study efficiency, and student satisfaction compared to traditional outline (OUT) format. A mixed-methods prospective randomized crossover trial was undertaken with veterinary students (n = 31) in an elective cardiology course. All students received identical content presented via weekly in-class lectures. Following 8 pre-designated lectures, students were given instructor-prepared study aids in either GO or OUT format. Students completed quizzes of content knowledge for each lesson and indicated amount of time spent studying. Crossover occurred such that groups of students alternated between receiving GO and OUT. Quantitative and qualitative data were collected in the form of in-depth pre- and post-course surveys. Quiz scores did not differ (p = .42) based on type of study aid provided (GO vs. OUT). Students spent an average of 17% less time studying per lesson when using GO compared to OUT (p = .05). Student satisfaction with both study aid formats was high, but students preferred GO over OUT in terms of study efficiency (p = .002), visual appeal (p < .001), ease of use (p < .004), and likelihood of referencing in the future (p < .001). In an elective veterinary cardiology course, use of GO compared to OUT format study aids resulted in higher study efficiency and student satisfaction with equivalent short-term learning outcomes.

Evaluation of culture-specific popular music as a mental metronome for cardiopulmonary resuscitation: a randomised crossover trial

Introduction: Bystander cardiopulmonary resuscitation (CPR) improves survival in out-of-hospital cardiac arrest. The use of certain songs as mental metronomes for CPR have been validated and recognised by contemporary guidelines. We hypothesise that the National Day song, Count on me Singapore (COMS CPR), is not inferior to standard ‘one-and-two-and-three-and-four’ counting (standard CPR) for timing CPR, in terms of the proportion of participants achieving the guideline compression rate of 100–120/minute. Methods: This was a prospective randomised crossover trial powered to demonstrate non-inferiority in the CPR rate. After a familiarisation session, volunteers were randomly assigned to two groups. Group A performed one cycle of standard CPR while group B performed one cycle of COMS CPR. Participants then crossed over to perform the other method. The Laerdal SkillReporter measured CPR quality. Four weeks later, participants attended a test scenario, using standard CPR or COMS CPR (randomly allocated). Results: Ninety subjects were recruited; 46 were randomly assigned to group A and 44 to group B. Baseline characteristics were similar; 41.1% of COMS CPR achieved 100–120/minute, versus 28.9% of standard CPR ( P=0.028). In mixed effects logistical regression, significantly more COMS CPR was performed at 100–120/minute compared to standard CPR (odds ratio 2.44, 95% confidence interval 1.01–5.9, P=0.047). The proportion of insufficient depth was higher in COMS CPR (80.59% vs. 68.01%, P&lt;0.001). There were no differences in other aspects of CPR quality. There were no differences in CPR quality between standard CPR and COMS CPR during the follow-up. Conclusion: COMS CPR was not inferior in terms of the proportion of participants delivering a guideline-compliant rate of chest compression. COMS CPR may have applications to layman CPR education, such as in mass education events.

Comparative evaluation of laryngeal view and intubating conditions in two laryngoscopy positions-attained by conventional 7 cm head raise and that attained by horizontal alignment of external auditory meatus - sternal notch line – using an inflatable pillow - A prospective randomised cross-over trial

Background and Aims:We compared the laryngoscopy position attained by a 7-cm-high pillow (Sniffing position-SP) with that attained by horizontal alignment of external auditory meatus-sternal notch (AM-S) line-using variable height inflatable pillow.Material and Methods:This prospective-randomised-cross-over study included 50 patients in each group. Group-AM-S: A 7 cm uncompressible pillow was used for attaining first laryngoscopy position, followed by horizontal alignment of external auditory meatus-sternal notch (AM-S) line-using an inflatable pillow for attaining second laryngoscopy position followed by intubation. Group-SP: Horizontal alignment of external auditory meatus-sternal notch (AM-S) line-was done using an inflatable pillow for attaining first laryngoscopy position, followed by using 7 cm uncompressible pillow for second laryngoscopy position followed by intubation. The CL-grade, Intubation Difficulty Score (IDS) and time to intubation were compared in both positions. The head raise (in cm) required for attaining AM-S alignment was noted.Results:CL-grade-I was obtained in significantly larger number of patients with AM-S alignment position than with 7 cm head raise (P = 0.004). CL-grade-III was obtained in significantly lesser number of patients with AM-S alignment (P = 0.002). Mean IDS with AM-S alignment (1.18 ± 1.69) was significantly less than with 7cm head raise (2 ± 1.59; P = 0.007) and time to intubation with AM-S alignment (17.33 ± 4.52 s) was significantly less than that with 7cm head raise (18.94 ± 4.64 s; P = 0.041). The mean head rise required to achieve AM-S line alignment was 4.920 ± 1.460 cm.Conclusion:External Auditory Meatus-Sternal notch (AM-S) line alignment provides better laryngeal view, better intubating conditions and requires lesser time to intubate as compared to a conventional 7-cm-head raise. The size of pillow used for head raise should be individualised.

Impact of Hand Dominance on Effectiveness of Chest Compressions in a Simulated Setting: A Randomised, Crossover Trial

Aim External cardiac compressions (ECC) are a critical component in determining the effectiveness of cardiopulmonary resuscitation (CPR). Guidelines prior to the 2010 International Liaison Committee on Resuscitation directed rescuers to place the heel of the dominant hand directly on the chest when performing ECC, however current guidelines are silent on this issue. Existing research is inconsistent in findings, and heterogeneous in design and participants. The aims of this pilot study were to: 1) investigate the impact of hand dominance on effectiveness of ECC; and 2) generate outcome data to inform sample size calculations for a larger future study. Methods This study utilised a single blinded, prospective randomised crossover trial design. Each participant was allocated to a ‘dominant hand on chest’ (DHOC) or ‘non-dominant hand on chest’ (NDHOC) group. On a simulation manikin, participants in the DHOC group performed 3 minutes of ECC with dominant hand on the chest and non-dominant hand supporting, followed by a ‘rest and recovery’ period and then a second 3-minute period of ECC with the hand reversed such that the non-dominant hand was on the chest. The NDHOC group performed the same series of compressions but in reverse order. The primary outcome measure was effectiveness of ECC, determined by a percentage-based ‘CPR score’ (‘CS’). Secondary outcomes were compression depth, rate and release. The Wilcoxon rank-sum (Mann-Whitney) test was used due to the non-normal distribution of the data. Due to the crossover design, hierarchical linear regression was used to assess for a period or cross over effect. Results For the primary outcome of this study, we have found no significant difference in CS between DHOC and NDHOC (69.9% (SD=29.9) vs. 69.1% (SD=34.1); p=0.92), respectively. There were no differences in the secondary outcomes of compression rate and depth, though compression release was improved in the DHOC group (53% vs. 42%; p=0.02). Conclusion In this randomised crossover study conducted in a simulation context there was no difference in ECC effectiveness measured by an overall effectiveness outcome according to placement of the dominant or non-dominant hand on the chest during compressions. A modest improvement in ECC release was seen in the dominant hand on chest group. While the study was underpowered, the results support an approach involving rescuers placing whichever hand they are most comfortable with on the chest irrespective of handedness.

Randomized crossover trial comparing effectiveness and tolerability of generic and brand-name travoprost

ObjectiveThe primary goal is to determine if the intraocular pressure reducing effect of generic Sandoz travoprost is equivalent to that of brand-name Travatan Z. The secondary goal is to determine if generic Sandoz travoprost is as well tolerated as Travatan Z. MethodsThis prospective randomized crossover trial allocated 76 patients with primary open-angle glaucoma, normotensive glaucoma, or ocular hypertension in a 1:1 ratio to start with either generic Sandoz travoprost or Travatan Z. Crossover happened after 3 weeks. The primary endpoint, intraocular pressure, was measured in both eyes at baseline, at week 3, and at week 6. The secondary endpoint was tolerability of both drugs as assessed by a questionnaire administered at week 3 and week 6. ResultsThe intraocular pressure lowering effect of generic Sandoz travoprost was equivalent to that of Travatan Z (18.20 ± 3.41 mmHg and 18.44 ± 3.48 mmHg respectively, p < 0.0001). Tolerability, as measured with a questionnaire, was similar between the two formulations of travoprost. ConclusionThis study is the first to compare a brand-name travoprost with one of its generic forms and adds to the body of evidence that generic glaucoma eye drops are as effective and well-tolerated as their brand name counterparts. The intraocular pressure lowering effect of generic Sandoz travoprost is equivalent to that of Travatan Z. Patient tolerance of generic and brand-name travoprost is similar.

Effects of Citrate Acid Concentrate on Hemodialysis Adequacy, Reuse, and Quality of Life: A Prospective Randomized Crossover Trial.

We conducted a randomized crossover trial to identify whether the use of citrate dialysate (CD) for bicarbonate hemodialysis is beneficial compared to regular acetate dialysate (AD) in terms of adequacy, reuse, and quality of life. Thirty-two stable end-stage renal disease patients on twice-weekly maintenance hemodialysis were randomly assigned to CD or AD fluid in a single-blinded randomized prospective crossover trial of 1-year duration. The primary outcomes studied were the impact of CD in comparison with AD on hemodialysis adequacy, reuse of dialyzer, and quality of life. Secondary outcomes studied were the effect on intradialytic hypotension, acidosis correction, and episodes of symptomatic hypocalcemia. A total number of 28 patients underwent a total of 1456 sessions of hemodialysis with CD over 6 months and 1456 sessions with AD over 6 months. There was a significant increase in dialyzer reuse with the use of CD (P = 0.02). There was no difference in dialyzer adequacy as measured by Single pool Kt/V (spKt/V) (P = 0.840) and urea reduction ratio (%) (P = 0.90). Quality of life did not differ between the two groups. No statistically significant difference was observed in predialysis arterial pH (P = 0.23) serum bicarbonate (0.17) and calcium change (P = 0.16). CD is safe and equally effective as compared to AD. It significantly improves the reuse of dialyzer but it does not offer any added advantage in terms of improvement in hemodialysis adequacy and quality of care.

A novel algorithm increases the delivery of effective cardiac resynchronization therapy during atrial fibrillation: The CRTee randomized crossover trial

Cardiac resynchronization therapy (CRT) requires a high percentage of ventricular pacing (%Vp) to maximize its clinical benefits. Atrial fibrillation (AF) has been shown to reduce %Vp in CRT due to competition with irregular intrinsic atrioventricular (AV) conduction. We report the results of a prospective randomized crossover trial evaluating the amount of effective CRT delivered during AF with a novel algorithm (eCRTAF). The purpose of this study was to determine whether eCRTAF increases the amount of effective CRT delivered during AF compared to a currently available rate regularization algorithm. Patients previously implanted with a cardiac resynchronization therapy-defibrillator and with a history of AF and intact AV conduction received up to 4 weeks of control (Conducted AF Response) and up to 4 weeks of eCRTAF in a randomized sequence. The percent effective CRT (%eCRT) pacing, which excludes beats without left ventricular capture, %Vp, and mean heart rate (HR) were recorded during AF and sinus rhythm. The eCRTAF algorithm resulted in a significantly higher %eCRT during AF than control (87.8% ± 7.8% vs 80.8% ± 14.3%; P<.001) and %Vp during AF than control (90.0% ± 5.9% vs 83.2% ± 11.9%; P <.001), with a small but statistically significant increase in mean HR of 2.5 bpm (79.5 ± 9.7 bpm vs 77.0 ± 9.9 bpm; P <.001). In a cohort of CRT patients with a history of AF, eCRTAF significantly increased %eCRT pacing and %Vp during AF with a small increase in mean HR. This algorithm may represent a novel noninvasive method of significantly increasing effective CRT delivery during AF, potentially improving CRT response.

Effect of gum chewing on gastric volume and emptying: a prospective randomized crossover study

BackgroundCurrent fasting guidelines allow oral intake of water up to 2 h before induction of anaesthesia. We assessed whether gum chewing affects gastric emptying of 250 ml water and residual gastric fluid volume measured 2 h after ingestion of water. MethodsThis prospective randomized observer-blind crossover trial was performed on 20 healthy volunteers who attended two separate study sessions: Control and Chewing gum (chlorophyll flavour, with 2.1 g carbohydrate). Each session started with an ultrasound measurement of the antral area, followed by drinking 250 ml water. Then, volunteers either chewed a sugared gum for 45 min (Chewing gum) or did not (Control). Serial measurements of the antral area were performed during 120 min, and the half-time to gastric emptying (t½), total gastric emptying time, and gastric fluid volume before ingestion of water and 120 min later were calculated. ResultsGastric emptying of water was not different between sessions; the mean (sdsd) t½ was 23 (10) min in the Control session and 21 (7) min in the Chewing gum session (P=0.52). There was no significant difference between sessions in gastric fluid volumes measured before ingestion of water and 120 min later. ConclusionsChewing gum does not affect gastric emptying of water and does not change gastric fluid volume measured 2 h after ingestion of water. Clinical trial registrationNCT02673307.

Cadaveric study of movement in the unstable upper cervical spine during emergency management: tracheal intubation and cervical spine immobilisation—a study protocol for a prospective randomised crossover trial

IntroductionEmergency management of upper cervical spine injuries often requires cervical spine immobilisation and some critical patients also require airway management. The movement of cervical spine created by tracheal intubation and...

Comparison of radial endobronchial ultrasound with a guide sheath and with distance by thin bronchoscopy for the diagnosis of peripheral pulmonary lesions: a prospective randomized crossover trial.

Transbronchial biopsy (TBB) using radial endobronchial ultrasound with a guide sheath (REBUS-GS) has improved the diagnosis of peripheral pulmonary lesions (PPLs). Because of the high cost of the GS, REBUS with distance (REBUS-D) has certain advantages. The aim of this study was to compare the diagnostic yield of the REBUS-GS and REBUS-D by thin bronchoscopy for PPLs. Patients with PPLs were enrolled in a prospective randomized crossover study from August 2014 and July 2015. Once the lesion was localized, TBB using REBUS-GS and TBB using REBUS-D were performed sequentially in a randomized order in each patient. Each patient received four to five transbronchial biopsies with REBUS-GS as well as four to five transbronchial biopsies with REBUS-D. All brushing was performed through GS. A total of 54 patients were enrolled in this study. After excluding seven participants with PPLs that were not detected by REBUS, a total of 47 subjects underwent REBUS-TBB. The diagnostic yield of REBUS-GS-TBB and REBUS-D-TBB was 72.2% (39/54) and 75.9% (41/54) respectively (P=0.625). Moreover, there was no statistically significant difference in diagnostic yield between REBUS-GS and REBUS-D in different lobe lesions and lesion sizes. Two cases of adenocarcinoma were only diagnosed with REBUS-GS-TBB. Two cases of tuberculosis, one case of mucosa-associated lymphoid tissue lymphoma (MALT) and one case of adenocarcinoma were only diagnosed by REBUS-D-TBB. The mean biopsy time after visualization of PPLs for REBUS-GS-TBB and REBUS-D-TBB were 5.17±2.34 and 7.36±3.18 min (P=0.00053). Using thin bronchoscopy, the diagnostic yield for PPLs with REBUS-D-TBB is not inferior to the yield with REBUS-GS-TBB. The diagnosis rate of small subpleural lesions with REBUS-D is lower than the rate with REBUS-GS. Although it is associated with shorter operation time and less bleeding, REBUS-GS has a higher cost and sometimes leads to check failure due to small specimens and the impact of the bronchoscope curvature.

Music intervention during daily weaning trials—A 6 day prospective randomized crossover trial

PurposeTo examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. MethodsUsing a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). ResultsOf 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (p<0.05). A multivariate mixed-effects model analysis that included patients who completed ≥2 days of the intervention (n=28) demonstrated significant decreases in HR, RR, VAS-A, and VAS-D and a significant increase in daily weaning duration on music days (p<0.05). ConclusionsProviding patient selected music during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process.

Hypnosis and Local Anesthesia for Dental Pain Relief—Alternative or Adjunct Therapy?—A Randomized, Clinical-Experimental Crossover Study

This prospective randomized clinical crossover trial was designed to compare hypnosis and local anesthesia for experimental dental pain relief. Pain thresholds of the dental pulp were determined. A targeted standardized pain stimulus was applied and rated on the Visual Analogue Scale (0–10). The pain threshold was lower under hypnosis (58.3 ± 17.3, p < .001), maximal (80.0) under local anesthesia. The pain stimulus was scored higher under hypnosis (3.9 ± 3.8) than with local anesthesia (0.0, p < .001). Local anesthesia was superior to hypnosis and is a safe and effective method for pain relief in dentistry. Hypnosis seems to produce similar effects observed under sedation. It can be used in addition to local anesthesia and in individual cases as an alternative for pain control in dentistry.

Target-Controlled Infusion of Propofol in Training Anesthesiology Residents in Colonoscopy Sedation: A Prospective Randomized Crossover Trial.

BackgroundPropofol is widely used in sedation for colonoscopy, but its adverse effects on cardiovascular and respiratory systems are still concerning. The present study investigated whether target controlled infusion (TCI) of propofol could provide a better sedation quality than manually controlled infusion (MCI) in training inexperienced anesthesiology residents.Material/MethodsEighteen training residents were allocated into 2 groups receiving TCI and MCI training in their first month in the endoscopy center, while receiving MCI and TCI training instead in their second month. The last 2 patients at the end of each month were included to analyze the sedation quality of TCI and MCI techniques by comparing satisfaction of endoscopist and patients based on the visual analogue scale (VAS). Heart rate (HR), mean blood pressure (MAP), SpO2, and recovery time were also compared as the secondary outcomes.ResultsThe demographic data were similarly distributed among the TCI and MCI patients. Endoscopist’s satisfaction score in the TCI group was significantly higher than in the MCI group, 81.3±7.2 versus 74.2±9.5 (P=0.003), but the patients’ satisfaction score was similar between the 2 groups. More stable hemodynamic status was obtained in the TCI group, manifested as higher lowest MAP and lower highest MAP than in the MCI group. Lowest SpO2 in the TCI group was significantly higher than in the MCI group. Patients in the TCI group recovered earlier than in the MCI group.ConclusionsTCI is a more effective and safer technique for anesthesiology residents in sedation for colonoscopy.

Comparison of the Feasibility and Safety of Nasotracheal Suctioning With Curved Edge Catheter Versus Conventional Suction Catheter in Critically Ill Subjects: A Prospective Randomized Crossover Trial

Nasotracheal suctioning (NTS) is accomplished by inserting a suction catheter into the trachea through the nasopharynx. It is a useful procedure in critically ill patients whose ability to cough and mobilize secretions is impaired. Ιt was assumed that using a suction catheter with an angular tip would facilitate entry into the trachea. The primary outcome was the success rate and the ease of insertion by using a curved edge catheter (Tiemann type) compared with a conventional suction catheter. The secondary outcome was the monitoring of subject's vital signs during the intervention. Non-intubated subjects hospitalized in 2 adult ICUs underwent 2 consecutive NTSs each, using either a 14 French curved edge catheter or a 14 French conventional suction catheter, randomly. Twenty subjects with a mean age of 75.5 y were enrolled for a time period of 5 months. The tracheal access success rate was 19/52 (successful/unsuccessful attempts) using a curved edge catheter (36.5%, 95% CI 23.6-51.0%) compared with 12/130 (9.2%, 95% CI 4.8-15.5%) using a conventional suction catheter. The insertion was 5.6 times more likely to be achieved by using a curved edge catheter (odds ratio 5.66, 95% CI 2.49-12.84, P < .001). The number of attempts required to succeed in the insertion was significantly lower when using a curved edge catheter than when using a conventional suction catheter (for nasopharynx, median [range] of 1 [1] versus 2.5 [8], P = .001; for trachea, median [range] of 2 [9] versus 9 [9], P = .002). The time required for successful insertion into the nasopharynx and trachea was significantly shorter when using a curved edge catheter than when using a conventional suction catheter (for nasopharynx, median [range] of 3 [11] s versus 5.3 [18] s, P = .038; for trachea, median [range] of 6 [27] s versus 20 [25] s, P = .002). The traumatic rate (percentage of catheters with blood present on the tip) was exactly the same for both catheters (30%). It is more likely that tracheal access will be achieved using a curved edge catheter. A shorter process time and fewer attempts are required for successful NTS using a curved edge catheter, and it seems to be an equally safe procedure. (ClinicalTrials.gov registration NCT02261428.).

Oral Tranexamic Acid versus Combined Oral Contraceptives for Adolescent Heavy Menstrual Bleeding: A Pilot Study

Study ObjectiveTo compare the efficacy of oral tranexamic acid (TA) with combined oral contraceptives (COC) in reducing menstrual blood loss (MBL) and improving quality of life in adolescent heavy menstrual bleeding (HMB). Design, Setting, and ParticipantsA prospective randomized crossover trial with 17 postmenarchal girls aged 21 years and younger with HMB who were seen at our institution. InterventionsPatients were randomized to group A (TA arm) or group B (COC arm), each for 3 cycles, with crossover to the second arm after 1-month washout. Main Outcome MeasuresThe primary end points were difference in improvement in MBL and QOL, from baseline to end of each therapy. ResultsSeventeen patients were enrolled (mean age 14.2 years, range 11.7 to 16.8 years). Nine patients completed both arms; 8 patients withdrew from the study due to adverse events or noncompliance. Compared with baseline, significant improvement (P < .05) was demonstrated by TA and COC in MBL (mean Pictorial Blood Assessment Chart score decrease: TA, 536.4; COC, 430.6) and quality of life (mean Pediatric Quality of Life InventoryTM version 4.0 Generic Scales score increase: TA, 15.6; COC, 16.75), but no significant difference was noted between TA and COC (P > .05). There was statistically significant reduction in the length of menstrual cycle for COC only (mean reduction 5.3 days; P = .04) and not for TA (P = .18). Ten patients (58%) experienced adverse events that were possibly drug related (TA: n = 3, 30%; COCP: n = 7, 64%). ConclusionIn this pilot study, oral TA appeared as efficacious as COC in the management of adolescent HMB by reducing MBL and improving quality of life.