Factors Associated With Spontaneous Awakening Trial and Spontaneous Breathing Trial Performance in Adults With Critical Illness: Analysis of a Multicenter, Nationwide, Cohort Study.

BACKGROUND: Broad-scale adoption of spontaneous awakening trials (SATs) and spontaneous breathing trials (SBTs) into everyday practice has been slow, and uncertainty exists regarding what factors facilitate or impede their routine delivery. RESEARCH QUESTION: What patient, practice, and pharmacologic factors are associated with SAT and SBT performance and to what extent do they predict overall SAT/SBT performance? STUDY DESIGN AND METHODS: This secondary analysis used data collected from a national quality improvement collaborative composed of 68 diverse ICUs. Adults with critical illness adults who received mechanical ventilation and/or continuously infused sedative medications were included. We performed mixed-effects logistic regression modeling, created receiver operating characteristic curves, and calculated the area under the curve (AUC). RESULTS: Included in the SAT and SBT analysis were 4,847 and 4,938 patients, respectively. In multivariable models controlling for admitting patient characteristics, factors independently associated with higher odds of a next-day SAT and SBT included physical restraint use (adjusted odds ratio [AOR], 1.63; 95% CI, 1.42-1.87; AOR, 1.83; 95% CI, 1.60-2.09), documented target sedation level (AOR, 1.68; 95% CI, 1.41-2.01; AOR, 1.46; 95% CI, 1.24-1.72), more frequent level of arousal assessments (AOR, 1.22; 95% CI, 1.03-1.43; AOR, 1.32; 95% CI, 1.13-1.54), and dexmedetomidine administration (AOR, 1.23; 95% CI, 1.05-1.45; AOR, 1.52; 95% CI, 1.27-1.80). Factors independently associated with lower odds of a next-day SAT and SBT included deep sedation/coma (AOR, 0.69; 95% CI, 0.60-0.80; AOR, 0.33; 95% CI, 0.28-0.37) and benzodiazepine (AOR, 0.83; 95% CI, 0.72-0.95; AOR, 0.67; 95% CI, 0.59-0.77) or ketamine (AOR, 0.34; 95% CI, 0.16-0.71; AOR, 0.40; 95% CI, 0.18-0.88) administration. Models incorporating admitting, daily, and unit variations displayed moderate discriminant accuracy in predicting next-day SAT (AUC, 0.73) and SBT (AUC, 0.72) performance. INTERPRETATION: There are a number of modifiable factors associated with SAT/SBT performance that are amenable to the development and testing of implementation interventions.

Design of Clinical Trials Evaluating Sedation in Critically Ill Adults Undergoing Mechanical Ventilation: Recommendations From Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research (SCEPTER) Recommendation III.

OBJECTIVES: Clinical trials evaluating the safety and effectiveness of sedative medication use in critically ill adults undergoing mechanical ventilation differ considerably in their methodological approach. This heterogeneity impedes the ability to compare results across studies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations convened a meeting of multidisciplinary experts to develop recommendations for key methodologic elements of sedation trials in the ICU to help guide academic and industry clinical investigators. DESIGN: A 2-day in-person meeting was held in Washington, DC, on March 28-29, 2019, followed by a three-round, online modified Delphi consensus process. PARTICIPANTS: Thirty-six participants from academia, industry, and the Food and Drug Administration with expertise in relevant content areas, including two former ICU patients attended the in-person meeting, and the majority completed an online follow-up survey and participated in the modified Delphi process. MEASUREMENTS AND MAIN RESULTS: The final recommendations were iteratively refined based on the survey results, participants' reactions to those results, summaries written by panel moderators, and a review of the meeting transcripts made from audio recordings. Fifteen recommendations were developed for study design and conduct, subject enrollment, outcomes, and measurement instruments. Consensus recommendations included obtaining input from ICU survivors and/or their families, ensuring adequate training for personnel using validated instruments for assessments of sedation, pain, and delirium in the ICU environment, and the need for methodological standardization. CONCLUSIONS: These recommendations are intended to assist researchers in the design, conduct, selection of endpoints, and reporting of clinical trials involving sedative medications and/or sedation protocols for adult ICU patients who require mechanical ventilation. These recommendations should be viewed as a starting point to improve clinical trials and help reduce methodological heterogeneity in future clinical trials.