Expert Consensus Statements for the Management of a Physiologically Difficult Airway Using the Delphi Method (PDADelphi)

NCT05762068 | Completed

• 1 other identifier: STU-2023-XXXX
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to review/identify the existing definition and management strategies for a physiologically difficult airway (PDA), to generate expert consensus on the various aspects of managing a patient with a PDA using the Delphi method, and to provide guidance to clinicians worldwide on safe tracheal intubation practices in patients with PDA to help improve patient outcomes.

Conditions

Intubation; Difficult or Failed; Intubation Complication; Hemodynamic Instability; Critical Illness

Keywords

Tracheal intubation; Difficult airway; Physiologically Difficult Airway; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Consensus statements

  Consensus amongst the expert panel regarding physiologically difficult airway (PDA) management will be achieved using Delphi method which includes iterative rounds of questions. Consensus will be considered reached when a statement achieves \>80% of votes for multiple-choice questions and \>70% for Likert-scale statements.

  Through study completion, an average of 12 months

Study Arms (1)

Airway management experts

The Steering Committee selected Experts from across the globe based on pre-defined criteria and will conduct iterative Delphi rounds to generate consensus among the experts.

Other: Delphi procedure

Interventions

Delphi procedure OTHER

The study involves generating consensus statements by experts on airway management in critically ill patients on the definition and management of a physiologically difficult airway (PDA) using a Delphi process.

Airway management experts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Experts must meet the following three criteria: Clinical expertise in the airway management of critically ill patients, teaching experience in airway management, and have/had research projects and/or publications in airway management

You may qualify if:

• Clinical expertise in the airway management of critically ill patients
• Teaching experience in airway management
• Research projects and/or publications in airway management

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75225, United States

Location

Related Publications (7)

• Mosier JM, Joshi R, Hypes C, Pacheco G, Valenzuela T, Sakles JC. The Physiologically Difficult Airway. West J Emerg Med. 2015 Dec;16(7):1109-17. doi: 10.5811/westjem.2015.8.27467. Epub 2015 Dec 8.

  PMID: 26759664 RESULT

• Myatra SN, Divatia JV, Brewster DJ. The physiologically difficult airway: an emerging concept. Curr Opin Anaesthesiol. 2022 Apr 1;35(2):115-121. doi: 10.1097/ACO.0000000000001102.

  PMID: 35165233 RESULT

• Russotto V, Myatra SN, Laffey JG, Tassistro E, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Pelosi P, Sorbello M, Higgs A, Greif R, Putensen C, Agvald-Ohman C, Chalkias A, Bokums K, Brewster D, Rossi E, Fumagalli R, Pesenti A, Foti G, Bellani G; INTUBE Study Investigators. Intubation Practices and Adverse Peri-intubation Events in Critically Ill Patients From 29 Countries. JAMA. 2021 Mar 23;325(12):1164-1172. doi: 10.1001/jama.2021.1727.

  PMID: 33755076 RESULT

• Karamchandani K, Wheelwright J, Yang AL, Westphal ND, Khanna AK, Myatra SN. Emergency Airway Management Outside the Operating Room: Current Evidence and Management Strategies. Anesth Analg. 2021 Sep 1;133(3):648-662. doi: 10.1213/ANE.0000000000005644.

  PMID: 34153007 RESULT

• Kornas RL, Owyang CG, Sakles JC, Foley LJ, Mosier JM; Society for Airway Management's Special Projects Committee. Evaluation and Management of the Physiologically Difficult Airway: Consensus Recommendations From Society for Airway Management. Anesth Analg. 2021 Feb 1;132(2):395-405. doi: 10.1213/ANE.0000000000005233.

  PMID: 33060492 RESULT

• Diamond IR, Grant RC, Feldman BM, Pencharz PB, Ling SC, Moore AM, Wales PW. Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. J Clin Epidemiol. 2014 Apr;67(4):401-9. doi: 10.1016/j.jclinepi.2013.12.002.

  PMID: 24581294 RESULT

• Nasa P, Jain R, Juneja D. Delphi methodology in healthcare research: How to decide its appropriateness. World J Methodol. 2021 Jul 20;11(4):116-129. doi: 10.5662/wjm.v11.i4.116. eCollection 2021 Jul 20.

  PMID: 34322364 RESULT

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kunal Karamchandani, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: February 20, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

US (1)