Rate Of Respiratory Adverse Events Research Articles

Outcomes and predictors of delayed endoscopic biliary drainage for severe acute cholangitis due to choledocholithiasis in an intensive care unit.

Acute cholangitis (AC) is an infection of the biliary tract secondary to biliary obstruction requiring biliary drainage through endoscopic retrograde cholangiopancreatography. This study aims to compare the outcome between the early and delayed ERCP in patients with severe AC. Patient with severe AC due to choledocholithiasis admitted to intensive care unit were included. Early ERCP was defined was as ERCP performed within 24h following hospital admission. Propensity-score matching was used to reduce the imbalance between groups. The primary outcome was 30-day mortality. Secondary outcomes included length of hospital and ICU stay, onset or persistent organ failure. The delayed ERCP group had a higher mortality rate at 30 days (45,5 versus 13%, <0.001) and at 1 year (59,7% versus 15,6%, p <0.001). Delayed ERCP had also a higher rate of respiratory adverse events (54,5 versus 27,8%, p=0,002), longer ICU (7.41 versus 4.61, p=0,004) and hospital (11,88 versus 9,22, p=0,042) length of stay. Predictors of delayed ERCP were cardiac arrythmias, liver disease, creatinine value and white blood cell count at baseline. Delays in ERCP for patients with severe AC appear to be associated with higher mortality rate and prolonged ICU and hospital stays.

Crossover Patient Outcomes for Targeted Lung Denervation in Moderate to Severe Chronic Obstructive Pulmonary Disease: AIRFLOW-2

Background: Targeted Lung Denervation (TLD) is a potential new therapy for COPD. Radiofrequency energy is bronchoscopically delivered to the airways to disrupt pulmonary parasympathetic nerves, to reduce bronchoconstriction, mucus hypersecretion, and bronchial hyperreactivity. Objectives: This work assesses the effect of TLD on COPD exacerbations (AECOPD) in crossover subjects in the AIRFLOW-2 trial. Method: The AIRFLOW-2 trial is a multicentre, randomized, double-blind, sham-controlled crossover trial of TLD in COPD. Patients with symptomatic COPD on optimal medical therapy with an FEV1 of 30–60% predicted received either TLD or sham bronchoscopy in a 1:1 randomization. Those in the sham arm had the opportunity to cross into the treatment arm after 12 months. The primary end point was rate of respiratory adverse events. Secondary end points included adverse events, changes in lung function and health-related quality of life and symptom scores. Results: Twenty patients were treated with TLD in the crossover phase and were subsequently followed up for 12 months (50% female, mean age 64.1 ± 6.9 years). After TLD, there was a trend towards a reduction in time to first AECOPD (hazard ratio 0.65, p = 0.28, not statistically significant) in comparison to sham follow-up period. There was also a reduction in time to first severe AECOPD in the crossover period (hazard ratio 0.38, p = 0.227, not statistically significant). Symptom scores and lung function showed stability. Conclusions: AIRFLOW-2 crossover data support that of the randomization phase, showing trends towards reduction in COPD exacerbations with TLD.

A novel nomogram for predicting respiratory adverse events during transport after interventional cardiac catheterization in children.

The rate and predictors of respiratory adverse events (RAEs) during transport discharged from operating room after interventional cardiac catheterization in children remain unclear. This study aimed to investigate the incidence and predictors, and to construct a nomogram for predicting RAEs during transport in this pediatric surgical treatment. This prospective cohort study enrolled 290 consecutive pediatric patients who underwent ventricular septal defects (VSD), atrial septal defects (ASD), and patent ductus arteriosus (PDA) between February 2019 and December 2020. Independent predictors were used to develop a nomogram, and a bootstrap resampling approach was used to conduct internal validation. Composite RAEs were defined as the occurrence of at least 1 complication regarding laryngospasm, bronchospasm, apnea, severe cough, airway secretions, airway obstruction, and oxygen desaturation. The rate of RAEs during transport was 23.1% (67 out of 290). Multivariate analysis identified age (vs. ≤3 years, adjusted odds ratio (aOR) = 0.507, 95% confidence interval (CI), 0.268-0.958, P = 0.036), preoperative upper respiratory tract infections (URI, aOR = 2.335, 95% CI, 1.223-4.460, P = 0.01), type of surgery (vs. VSD, for ASD, aOR = 2.856, 95% CI, 1.272-6.411, P = 0.011; for PDA, aOR = 5.518, 95% CI, 2.425-12.553, P < 0.001), morphine equivalent (vs. ≤0.153 mg/kg, aOR = 2.904, 95% CI, 1.371-6.150, P = 0.005), atropine usage (aOR = 0.463, 95% CI, 0.244-0.879, P = 0.019), and RAEs during extubation to transport (aOR = 5.004, 95% CI, 2.633-9.511, P < 0.001) as independent predictors of RAEs during transport. These six candidate predictors were used to develop a nomogram, which showed a C-statistic value of 0.809 and good calibration (P = 0.844). Internal validation revealed similarly good discrimination (C-statistic, 0.782; 95% CI, 0.726-0.837) and calibration. Decision curve analysis (DCA) also demonstrated the clinical usefulness of the nomogram. The high rate of RAEs during transport reminds us of the need for more medical care and attention. The proposed nomogram can reliably identify pediatric patients at high risk of RAEs during transport and guide clinicians to make proper transport plans. Our findings have important and meaningful implications for RAEs risk prediction, clinical intervention and healthcare quality control.

Terlipressin and the Treatment of Hepatorenal Syndrome: How the CONFIRM Trial Moves the Story Forward

Hepatorenal syndrome (HRS) is a form of acute kidney injury (AKI) occurring in patients with advanced cirrhosis and is associated with significant morbidity and mortality. The pathophysiology underlying HRS begins with increasing portal pressures leading to the release of vasodilatory substances that result in pooling blood in the splanchnic system and a corresponding reduction in effective circulating volume. Compensatory activation of the sympathetic nervous system and the renin-angiotensin-aldosterone system and release of arginine vasopressin serve to defend mean arterial pressure but at the cost of severe constriction of the renal vasculature, leading to a progressive, often fulminant form of AKI. There are no approved treatments for HRS in the United States, but multiple countries, including much of Europe, use terlipressin, a synthetic vasopressin analogue, as a first-line therapy. CONFIRM (A Multi-Center, Randomized, Placebo Controlled, Double-Blind Study to Confirm Efficacy and Safety of Terlipressin in Subjects With Hepatorenal Syndrome Type 1), the third randomized trial based in North America evaluating terlipressin, met its primary end point of showing greater rates of HRS reversal in the terlipressin arm. However, due to concerns about the apparent increased rates of respiratory adverse events and a lack of evidence for mortality benefit, terlipressin was not approved by the Food and Drug Administration (FDA). We explore the history of regulatory approval for terlipressin in the United States, examine the results from CONFIRM and the concerns they raised, and consider the future role of terlipressin in this critical clinical area of continued unmet need.

The predictive value of preimplant pulmonary function testing in LVAD patients

The predictive value of preoperative pulmonary function testing (PFT) in left ventricular assist device (LVAD) patients remains unknown. This study evaluates the relationship between abnormal PFTs and postimplant outcomes in LVAD patients. LVAD implants from January 2004 to December 2018 at a single institution were included. Patients were stratified based on the presence of abnormal preoperative PFTs, and the primary outcome was respiratory adverse events (AE). Secondary outcomes included 1-year overall postimplant survival, and complications including bleeding, renal failure, thromboembolism, and device malfunction. The total of 333 patients underwent LVAD implant, 46.5% (n = 155) with normal PFTs and 53.5% (n = 178) with abnormal PFTs. Patients with abnormal PFTs were noted to have higher rates of respiratory AEs (25.9% vs. 15.1%, p = .049). In multivariable analysis, the impact of PFTs was most significant when forced expiratory volume in 1 s/forced expiratory volume (FEV1/FVC) ratio was less than 0.5 (hazard ratio [HR] 16.32, 95% confidence interval [CI], 1.70-156.78). The rates of other AEs including bleeding, renal failure, right heart failure, and device malfunction were similar. One-year overall postimplant survival was comparable between the groups (56.8% vs. 68.8%, p = .3183), though patients in the lowest strata of FEV1 (<60% predicted) and FEV1/FVC (<0.5) had elevated risk-adjusted hazards for mortality (HR 2.63, 95% CI, 1.51-4.60 and HR 18.92, 95% CI, 2.10-170.40, respectively). The presence of abnormal preoperative PFTs is not prohibitory for LVAD implantation although it can be used for risk stratification for respiratory AEs and mortality, particularly in patients with severely reduced metrics. The importance of careful patient selection should be underscored in this higher risk patient subset.

Tezacaftor/ivacaftor in people with cystic fibrosis who stopped lumacaftor/ivacaftor due to respiratory adverse events

BackgroundIncreased rates of respiratory adverse events have been observed in people ≥12 years of age with cystic fibrosis homozygous for the Phe508del-CFTR mutation treated with lumacaftor/ivacaftor, particularly in those with percent predicted forced expiratory volume in 1 s (ppFEV1) of <40%. We evaluated the safety, tolerability, and efficacy of tezacaftor/ivacaftor in people with cystic fibrosis homozygous for Phe508del-CFTR who discontinued lumacaftor/ivacaftor due to treatment-related respiratory signs or symptoms. MethodsParticipants ≥12 years of age with cystic fibrosis homozygous for Phe508del-CFTR with ppFEV1 of ≥25% and ≤90% were randomized 1:1 and treated with tezacaftor/ivacaftor or placebo for 56 days. ResultsOf 97 participants, 94 (96.9%) completed the study. The primary endpoint was incidence of predefined respiratory adverse events of special interest (chest discomfort, dyspnea, respiration abnormal, asthma, bronchial hyperreactivity, bronchospasm, and wheezing): tezacaftor/ivacaftor, 14.0%; placebo, 21.3%. The adverse events were mild or moderate in severity. None were serious or led to treatment interruption or discontinuation. Overall, the discontinuation rate was similar between groups. The mean (SD) ppFEV1 at baseline was 44.6% (16.1%) with tezacaftor/ivacaftor and 48.0% (18.1%) with placebo. The posterior mean difference in absolute change in ppFEV1 from baseline to the average value of days 28 and 56 was 2.7 percentage points with tezacaftor/ivacaftor vs placebo. ConclusionsTezacaftor/ivacaftor was generally safe, well tolerated, and efficacious in people ≥12 years of age with cystic fibrosis homozygous for Phe508del-CFTR with ppFEV1 of ≥25% and ≤90% who previously discontinued lumacaftor/ivacaftor due to treatment-related respiratory signs or symptoms.

The Prognostic Value of Preoperative Pulmonary Function Testing in Patients Undergoing Left Ventricular Assist Device Implantation

This study evaluates the prognostic value of preoperative pulmonary function tests (PFTs) on post implant outcomes in LVAD patients. Durable LVAD implants from January 2004 to December 2018 at a single institution were included. The primary outcome was rates of respiratory adverse events (AEs): prolonged intubation >72 hours, pneumonia, reintubation or tracheostomy. Secondary outcome included survival. Criteria for abnormal PFTs was met with an FEV1 <80% predicted, FEV1/FVC <0.70, DLCO <45% predicted or TLC <80% predicted. Multivariable Cox regression was used for risk adjustment. 333 patients underwent LVAD implant, including 40.8% (n=136) with normal PFTs and 59.2% (n=197) with abnormal PFTs. Patients with abnormal PFTs had higher rates of respiratory AEs overall (26.1% vs 14.6%, p=0.04) (Figure A). Patients with abnormal PFTs had a 2-fold increased risk for respiratory AEs (HR 1.93, 95%CI 1.02, 1.64). After risk-adjustment, the impact of abnormal PFTs was most pronounced when FEV1 was <60% (HR 2.8, 95% CI 1.5, 6.7) and FEV1/FVC ratio was <0.5 (HR 43.6, 95% CI 5.8, 68.1). Although 43% (n=144) had a history of smoking and 25% (n=50) had a diagnosis of COPD, these factors did not influence the hazards for respiratory AEs. The rates of other AEs including bleeding, renal failure and right heart failure were similar (all p>0.05). Post-implant survival at 1 year follow-up was comparable between the groups (58.1% vs 73.7%, p=0.09) (Figure B), although patients in the lowest strata of FEV1 (<60%) and FEV1/FVC (<0.5) also had elevated hazards for risk-adjusted mortality (HR 2.7 95% CI 1.5, 4.9 and HR 36.4, 95% CI 4.2, 75.6). PFTs are a useful preoperative risk assessment tool for stratification and patient counseling regarding the likelihood of post-LVAD respiratory AEs. Patients with a FEV1 <60% or FEV1/FVC ratio <0.5 are at particularly high risk, demonstrating substantially increased hazards for respiratory AEs and 1-year mortality.

Salbutamol administered preoperatively to children undergoing tonsillectomy resulted in a significant reduction in rates of respiratory adverse events

Review of Von Ungern-Sternberg BS, Sommerfield D, Slevin L, Drake-Brockman TFE, Zhang G, Hall GL. Effect of albuterol premedication vs placebo on the occurrence of respiratory adverse events in children...

Postoperative Complications After Adenotonsillectomy in Two Paediatric Groups: Obstructive Sleep Apnoea Syndrome and Recurrent Tonsillitis

Introduction and objectivesAdenotonsillectomy is a surgery to treat recurrent tonsillitis or obstructive sleep apnoea syndrome (OSAS). It is considered a safe procedure, with few complications. Moreover, patients over 3 years and without comorbidities do not present a higher rate of respiratory adverse events after the immediate postoperative period, and do not need systematic admission to a paediatric intensive care unit (PICU), regardless of their OSAS severity. The aim of this study is to reanalyse the situation, including patients under the age of 3 years, for whom there are fewer available data, to confirm that this trend has not changed. MethodsA retrospective observational study was performed, including all adenotonsillectomised children in our hospital over 5 years. Results418 adenotonsillectomised children were included, 56.7% due to recurrent tonsillitis, and 43.3% because of OSAS. Only 24 patients (5.7%) experienced adverse events, of whom 1.2% had vomiting, 3.1% bleeding, and 1.4% respiratory events. All the respiratory events occurred in the operating theatre or in the post-anaesthetic unit, most frequently in children with severe OSAS, while the tonsillitis group had more bleeding (P=.046). No differences in complications were observed according to age (P=.174), but the group of patients under three years was relatively small. ConclusionsNo differences were found in the percentage of complications between the two groups. Although the OSAS group exhibited more respiratory events, these occurred in the immediate postoperative period; otherwise, there was a higher risk of bleeding in the tonsillitis group. These results support the findings indicating that routine PICU admission is not required for these patients.

Complicaciones postoperatorias tras adenoamigdalectomía en 2 grupos de pacientes pediátricos: síndrome de apnea-hipopnea del sueño e infecciones de repetición

Introduction and objectivesAdenotonsillectomy is a surgery to treat recurrent tonsillitis or obstructive sleep apnoea syndrome (OSAS). It is considered a safe procedure, with few complications. Moreover, patients over 3 years and without comorbidities do not present a higher rate of respiratory adverse events after the immediate postoperative period, and do not need systematic admission to a paediatric intensive care unit (PICU), regardless of their OSAS severity. The aim of this study is to reanalyse the situation, including patients under the age of 3 years, for whom there are fewer available data, to confirm that this trend has not changed. MethodsA retrospective observational study was performed, including all adenotonsillectomised children in our hospital over 5 years. Results418 adenotonsillectomised children were included, 56.7% due to recurrent tonsillitis, and 43.3% because of OSAS. Only 24 patients (5%7%) experienced adverse events, of whom 1.2% had vomiting, 3.1% bleeding, and 1.4% respiratory events. All the respiratory events occurred in the operating theatre or in the post-anaesthetic unit, most frequently in children with severe OSAS, while the tonsillitis group had more bleeding (P=.046). No differences in complications were observed according to age (P=0.174), but the group of patients under three years was relatively small. ConclusionsNo differences were found in the percentage of complications between the two groups. Although the OSAS group exhibited more respiratory events, these occurred in the immediate postoperative period; otherwise, there was a higher risk of bleeding in the tonsillitis group. These results support the findings indicating that routine PICU admission is not required for these patients.

Does the full-time presence of an intensivist lead to better outcomes in the cardiac surgical intensive care unit?

ObjectiveThe study objective was to compare clinical outcomes in a dedicated adult cardiac surgery intensive care unit before and after the implementation of 24-hour intensivist coverage. MethodsBetween 2008 and 2016, 16,454 consecutive adult patients were admitted to the cardiac surgery intensive care unit after cardiac surgery. During this period, postoperative patients in the cardiac surgery intensive care unit were managed by intensivists during the day (group A); in July 2010, the nighttime coverage was transferred from the hands of residents and fellows to intensivists (group B). Postoperative outcomes before and after this change using 1-to-1 propensity score matching were examined. Patients were stratified a priori into low- and high-risk (<5% and ≥5% predicted mortality) based on the European System for Cardiac Operative Risk Evaluation II. ResultsMatched patients in group A had significantly higher cardiac surgery intensive care unit (2.1% vs 1.4%, P = .01) and in-hospital (2.7% vs 1.8%, P = .008) mortality. This higher mortality was only observed among high-risk group A patients who had significantly higher rates of cardiac surgery intensive care unit mortality (6.8% vs 4.1%, P = .01) and in-hospital mortality (8.5% vs 5.3%, P = .01) compared with the high-risk group B. The median duration of mechanical ventilation (5.8 vs 4.3 hours, P < .0001) and the risk of prolonged ventilation greater than 48 hours (5.3% vs 4%, P = .008) were significantly higher among group A patients; this higher rate of respiratory adverse events was observed in all strata of preoperative risk. ConclusionsIn this large cohort of patients admitted to a dedicated adult cardiac surgery intensive care unit, 24-hour intensivist coverage was associated with reduced mortality among patients with an expected operative mortality 5% or greater. These data suggest that preoperative risk stratification and adaptive cardiac surgery intensive care unit physician staffing may result in improved clinical outcomes and optimized hospital resource use.

Tromboelastometría como guía de administración de hemoderivados en cirugía cardiaca

ObjectiveThromboelastometry is a viscoelastometric method for haemostasis testing in a whole blood sample. The aim of this study was to assess the results of using thromboelastometry as guidance for blood management in cardiac surgery, postoperative adverse events and ICU stay. Material and methodAnalytical and comparative non-randomised quasi-experimental prospective study with a retrospective control group. The inclusion criteria for the 80 patients were: patients undergoing cardiac surgery who had had prior cardiac surgery, endocarditis surgery or aortic arch surgery. Thirty-one patients were treated following routine transfusion practice during surgery (group A). The other 49 patients were treated with thromboelastometrically guided transfusion algorithms (group B).The main objective was blood products transfused, and postoperative adverse events and ICU stay were the secondary objectives. ResultsStatistical analysis showed lower transfusion rates of fresh-frozen plasma in group B compared to group A (P<.001), as well as red blood cell transfusion during surgery with an average transfusion rate of 3.9 units in group A in comparison to 2.67 units in group B (P=.125). Moreover, fibrinogen infusion was increased in group B compared to group A (P=.019). In addition, a lower rate of respiratory adverse events was found in group B (P=.019). There was a significant decrease in ICU stays over 7 days in group B compared to group A (P=.031). ConclusionsUsing thromboelastometry guidance for blood management led to a meaningful reduction of fresh frozen plasma transfusion during surgery. This probably resulted in a reduction in respiratory adverse events after surgery and length of ICU stay in our patients.

Risk stratification for the development of respiratory adverse events following vascular surgery using the Society of Vascular Surgery's Vascular Quality Initiative

ObjectivePostoperative respiratory adverse events (RAEs) are associated with high rates of morbidity and mortality in general surgery, however, little is known about these complications in the vascular surgery population, a frail subset with multiple comorbidities. The objective of this study was to describe the contemporary incidence of RAEs in vascular surgery patients, the risk factors for this complication, and the overall impact of RAEs on patient outcomes. MethodsThe Vascular Quality Initiative was queried (2003-2014) for patients who underwent endovascular abdominal aortic repair, open abdominal aortic aneurysm repair, thoracic endovascular aortic repair, suprainguinal bypass, or infrainguinal bypass. A mixed-effects logistic regression model determined the independent risk factors for RAEs. Using a random 85% of the cohort, a risk prediction score for RAEs was created, and the score was validated using the remaining 15% of the cohort, comparing the predicted to the actual incidence of RAE and determining the area under the receiver operating characteristic curve. The independent risk of in-hospital mortality and discharge to a nursing facility associated with RAEs was determined using a mixed-effects logistic regression to control for baseline patient characteristics, operative variables, and other postoperative adverse events. ResultsThe cohort consisted of 52,562 patients, with a 5.4% incidence of RAEs. The highest rates of RAEs were seen in current smokers (6.1%), recent acute myocardial infarction (10.1%), symptomatic congestive heart failure (9.9%), chronic obstructive pulmonary disease requiring oxygen therapy (11.0%), urgent and emergent procedures (6.4% and 25.9%, respectively), open abdominal aortic aneurysm repairs (17.6%), in situ suprainguinal bypasses (9.68%), and thoracic endovascular aortic repairs (9.6%). The variables included in the risk prediction score were age, body mass index, smoking status, congestive heart failure severity, chronic obstructive pulmonary disease severity, degree of renal insufficiency, ambulatory status, transfer status, urgency, and operative type. The predicted compared with the actual RAE incidence were highly correlated, with a correlation coefficient of 0.943 (P < .0001) and a c-statistic = 0.818. RAEs had a significantly higher rates of in-hospital mortality (25.4% vs 1.2%; P < .0001; adjusted odds ratio, 5.85; P < .0001), and discharge to a nursing facility (57.8% vs 19.0%; P < .0001; adjusted odds ratio, 3.14; P < .0001). ConclusionsRAEs are frequent and one of the strongest risk factors for in-hospital mortality and inability to be discharged home. Our risk prediction score accurately stratifies patients based on key demographics, comorbidities, presentation, and operative type that can be used to guide patient counseling, preoperative optimization, and postoperative management. Furthermore, it may be useful in developing quality benchmarks for RAE following major vascular surgery.

Effect of a quality program with adverse events identification on airway management during overtube-assisted enteroscopy.

Adverse events associated with overtube-assisted enteroscopy are similar to those with routine endoscopy. Our endoscopy quality program identified a number of respiratory adverse events resulting in emergency resuscitation efforts. The aim is to report all adverse events identified by quality monitoring and outcomes of adverse events associated with overtube-assisted enteroscopy. A retrospective study used data prospectively obtained from consecutive patients undergoing overtube-assisted enteroscopy between December 2008 and July 2012. Patient characteristics, medical history, procedure indication, and procedure outcomes, including diagnosis, endoscopic therapy, and complications, were obtained. In 432 overtube-assisted enteroscopies, 15 adverse events (most frequently hypoxemia, 9 /15, 60 %) occurred in 14 patients (3.2 % of total cohort; 12 were outpatients) mostly during antegrade enteroscopy. Four patients required endotracheal intubation and 4 /12 outpatients required intensive care. The procedure was aborted in 13 /14 patients, and only 1 of 10 patients scheduled for repeat antegrade enteroscopy returned. There was no mortality. Based on the frequency of adverse events, and in consultation with anesthesia providers, from August 2012 all antegrade overtube-assisted enteroscopies at our institution were done with general anesthesia. From then till September 2013, 145 antegrade and 52 retrograde overtube-assisted enteroscopies have been done, with no adverse events. Monitoring of endoscopy practice identified adverse events associated with overtube-assisted enteroscopy. The peer-review prompted a change in practice: all patients undergoing antegrade overtube-assisted enteroscopy at our institution now have endotracheal intubation which has dramatically decreased the rate of respiratory adverse events. The impact of endoscopic quality measurements on practices, procedures, and outcomes will be of further interest.

Safety of bronchial thermoplasty in patients with severe refractory asthma

BackgroundPatients with severe refractory asthma treated with bronchial thermoplasty (BT), a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle, were followed up for 5 years to evaluate long-term safety of this procedure. ObjectivesTo assess long-term safety of BT for 5 years. MethodsPatients with asthma aged 18 to 65 years requiring high-dose inhaled corticosteroids (ICSs) (>750 μg/d of fluticasone propionate or equivalent) and long-acting β2-agonists (LABAs) (at least 100 μg/d of salmeterol or equivalent), with or without oral prednisone (≤30 mg/d), leukotriene modifiers, theophylline, or other asthma controller medications were enrolled in the Research in Severe Asthma (RISA) Trial. Patients had a prebronchodilator forced expiratory volume in 1 second of 50% or more of predicted, demonstrated methacholine airway hyperresponsiveness, had uncontrolled symptoms despite taking maintenance medication, abstained from smoking for 1 year or greater, and had a smoking history of less than 10 pack-years. ResultsFourteen patients (of the 15 who received active treatment in the RISA Trial) participated in the long-term follow-up study for 5 years. The rate of respiratory adverse events (AEs per patient per year) was 1.4, 2.4, 1.7, and 2.4, respectively, in years 2 to 5 after BT. There was a decrease in hospitalizations and emergency department visits for respiratory symptoms in each of years 1, 2, 3, 4, and 5 compared with the year before BT treatment. Measures of lung function showed no deterioration for 5 years. ConclusionOur findings suggest that BT is safe for 5 years after BT in patients with severe refractory asthma. Trial Registrationclinicaltrials.gov Identifier: NCT00401986

Extubation of the Difficult Airway and Extubation Failure

Respiratory complications after tracheal extubation are associated with significant morbidity and mortality, suggesting that process improvements in this clinical area are needed. The decreased rate of respiratory adverse events occurring during tracheal intubation since the implementation of guidelines for difficult airway management supports the value of education and guidelines in advancing clinical practice. Accurate use of terms in defining concepts and describing distinct clinical conditions is paramount to facilitating understanding and fostering education in the treatment of tracheal extubation-related complications. As an example, understanding the distinction between extubation failure and weaning failure allows one to appreciate the need for pre-extubation tests that focus on assessing airway patency in addition to evaluating the ability to breathe spontaneously. Tracheal reintubation after planned extubation is a relatively rare event in the postoperative period of elective surgeries, with reported rates of reintubation in the operating room and postanesthesia care unit between 0.1% and 0.45%, but is a fairly common event in critically ill patients (0.4%-25%). Conditions such as obesity, obstructive sleep apnea, major head/neck and upper airway surgery, and obstetric and cervical spine procedures carry significantly increased risks of extubation failure and are frequently associated with difficult airway management. Extubation failure follows loss of upper airway patency. Edema, soft tissue collapse, and laryngospasm are among the most frequent mechanisms of upper airway obstruction. Planning for tracheal extubation is a critical component of a successful airway management strategy, particularly when dealing with situations at increased risk for extubation failure and in patients with difficult airways. Adequate planning requires identification of patients who have or may develop a difficult airway, recognition of situations at increased risk of postextubation airway compromise, and understanding the causes and underlying mechanisms of extubation failure. An effective strategy to minimize postextubation airway complications should include preemptive optimization of patients' conditions, careful timing of extubation, the presence of experienced personnel trained in advanced airway management, and the availability of the necessary equipment and appropriate postextubation monitoring.

Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial.

BackgroundBronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure.MethodsPatients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. Following initial evaluation at 1 year, subjects were invited to participate in a 4 year safety study. Adverse events (AEs) and spirometry data were used to assess long-term safety out to 5 years post-BT.Results45 of 52 treated and 24 of 49 control group subjects participated in long-term follow-up of 5 years and 3 years respectively. The rate of respiratory adverse events (AEs/subject) was stable in years 2 to 5 following BT (1.2, 1.3, 1.2, and 1.1, respectively,). There was no increase in hospitalizations or emergency room visits for respiratory symptoms in Years 2, 3, 4, and 5 compared to Year 1. The FVC and FEV1 values showed no deterioration over the 5 year period in the BT group. Similar results were obtained for the Control group.ConclusionsThe absence of clinical complications (based on AE reporting) and the maintenance of stable lung function (no deterioration of FVC and FEV1) over a 5-year period post-BT in this group of patients with moderate to severe asthma support the long-term safety of the procedure out to 5 years.

Risk factors for adverse events in children with colds emerging from anesthesia: a logistic regression

Recent upper respiratory infection (URI) in children increases respiratory adverse events following anesthesia for elective surgery. The increased risk continues weeks after resolution of acute URI symptoms. Few systematic analyses have explored specific risk factors. This logistic regression explores the relationship between preoperative URI symptoms and adverse events during emergence from anesthesia. Data were combined from control groups of several prospective observational and interventional studies in elective pediatric anesthesia in a tertiary care pediatric hospital. In each study, a blinded observer, distinct from the anesthesia care team, prospectively recorded the presence of stridor, oxygen desaturations (and their duration), coughing and laryngospasm. Parents were subsequently asked about the presence of 10 cold symptoms during the 6 weeks prior to operation. Our model, based on a dataset of 335 patients, did not demonstrate an association between any particular symptoms and the rate of respiratory adverse events during emergence from anesthesia, with the exception of low-grade fever which appeared to be mildly protective. Respiratory adverse events were affected by the airway management technique (device used and timing of extubation), and adverse events were increased if peak URI symptoms had occurred within the preceding 4 weeks. Specific preoperative symptoms were not useful in predicting respiratory adverse events during emergence from anesthesia.