HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

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.

AbstractOBJECTIVES:
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.
AuthorsDenham S Ward, Anthony R Absalom, Leanne M Aitken, Michele C Balas, David L Brown, Lisa Burry, Elizabeth Colantuoni, Douglas Coursin, John W Devlin, Franklin Dexter, Robert H Dworkin, Talmage D Egan, Doug Elliott, Ingrid Egerod, Pamela Flood, Gilles L Fraser, Timothy D Girard, David Gozal, Ramona O Hopkins, John Kress, Mervyn Maze, Dale M Needham, Pratik Pandharipande, Richard Riker, Daniel I Sessler, Steven L Shafer, Yahya Shehabi, Claudia Spies, Lena S Sun, Avery Tung, Richard D Urman
JournalCritical care medicine (Crit Care Med) Vol. 49 Issue 10 Pg. 1684-1693 (10 01 2021) ISSN: 1530-0293 [Electronic] United States
PMID33938718 (Publication Type: Journal Article)
CopyrightCopyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and Wolters Kluwer Health, Inc.
Chemical References
  • Hypnotics and Sedatives
Topics
  • Congresses as Topic
  • Consensus
  • Delphi Technique
  • District of Columbia
  • Humans
  • Hypnotics and Sedatives (pharmacokinetics, pharmacology, therapeutic use)
  • Respiration, Artificial (instrumentation, methods)
  • Time Factors

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: