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

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05762068
Collaborator
(none)
35
9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Delphi procedure

Detailed Description

The Delphi method involves the following 4 steps:

Step 1: Establishing a preliminary list of broad domains

A focused literature review was performed by select membership of the Society of Critical Care Anesthesiologists (SOCCA), and based on their input, the steering committee identified six broad domains, which were used to draft statements for Round one of the Delphi process.

List of domains:
  1. Definitions of PDA

  2. Preparing the team for airway management in a patient with PDA

  3. Preparing the patient with a PDA for success with airway management

  4. Performing tracheal intubation

  5. Post-intubation care

  6. Areas of Future Research

Step 2: Preparation of the Delphi Round One Survey The list of questions related to the above-mentioned domains will be sent to the Experts as a Delphi questionnaire. The anonymity of the Experts will be maintained during the Delphi rounds. The Experts would be requested to answer questions related to PDA based on their experience and knowledge of the subject. The questions will be multiple choice or in the form of a 7-point Likert scale (strongly agree, agree, somewhat agree, neither agree nor disagree, somewhat disagree, disagree, strongly disagree). The experts can also provide their opinion on addition, deletion on questions or choices through free-text. The responses of experts will be collated during the analysis of results and shared in the following survey as controlled feedback.

Step 3: Subsequent Delphi Rounds The steering committee will review the results of round one. The statements listed will be modified, deleted, or added if found ambiguous based on the feedback and comments of the results. The remaining statements will be continued in the subsequent rounds until consensus is achieved (>80% of respondents). The summary results of round two will be presented to experts, and the survey process will be repeated with the modified questionnaire. The Delphi rounds will be continued till desired consensus and stability is achieved for statements. We will also check the stability using chi-square test of the statements from Round 3 onwards and statement is said to be stable if p-value is > 0.05 for two consecutive rounds.

Step 4: Final Consensus The summary results of the last stable round will be used to issue the consensus on the various statements related to the above-mentioned domains. The results of the final survey, consensus statements, and the manuscript will be circulated among the experts for approval before submission for publication.

Study Design

Study Type:
Observational
Anticipated Enrollment :
35 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Expert Consensus Statements for the Management of a Physiologically Difficult Airway Using the Delphi Method (PDADelphi)
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. Consensus statements [Through study completion, an average of 12 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Clinical expertise in the airway management of critically ill patients

  • Teaching experience in airway management

  • Research projects and/or publications in airway management

Exclusion Criteria:
  • People don't meet the inclusion criteria

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Kunal Karamchandani, MD, UT Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kunal Karamchandani, Associate Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT05762068
Other Study ID Numbers:
  • STU-2023-XXXX
First Posted:
Mar 9, 2023
Last Update Posted:
Mar 9, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kunal Karamchandani, Associate Professor, University of Texas Southwestern Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2023