Intubation; Difficult or FailedPDADelphiNCT05762068
Expert Consensus Statements for the Management of a Physiologically Difficult Airway Using the Delphi Method (PDADelphi)
An observational study of Intubation; Difficult or Failed and Intubation Complication, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed, Intubation Complication, Hemodynamic Instability
- What is being tested?
- Delphi procedure
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 20 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Clinical expertise in the airway management of critically ill patients
- Teaching experience in airway management
- Research projects and/or publications in airway management
Who cannot join
- People don't meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75225
About this study
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.
Read the 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:
- Definitions of PDA
- Preparing the team for airway management in a patient with PDA
- Preparing the patient with a PDA for success with airway management
- Performing tracheal intubation
- Post-intubation care
- 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. The steering committee 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.
- Conditions
- Intubation; Difficult or Failed, Intubation Complication, Hemodynamic Instability, Critical Illness
- Being tested
- Delphi procedure
- Keywords
- Tracheal intubation, Difficult airway, Physiologically Difficult Airway, Critical Illness
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphi procedureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Delphi procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2023
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunal Karamchandani, University of Texas Southwestern Medical Center
- Investigators
- Kunal Karamchandani, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762068
- Sponsor's protocol ID
- STU-2023-XXXX
- Acronym
- PDADelphi
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26759664Myatra 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.
PubMed 35165233Russotto 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.
PubMed 33755076Karamchandani 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.
PubMed 34153007Kornas 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.
PubMed 33060492Diamond 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.
PubMed 24581294Nasa 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.
PubMed 34322364
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expert Consensus Statements for the Management of a Physiologically Difficult Airway Using the Delphi Method (PDADelphi)
- ClinicalTrials.gov ID
- NCT05762068
- Acronym / sponsor ID
- PDADelphi / STU-2023-XXXX
- Conditions
- Intubation; Difficult or Failed, Intubation Complication, Hemodynamic Instability, Critical Illness
- Keywords
- Tracheal intubation, Difficult airway, Physiologically Difficult Airway, Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Definitions of PDA
- Preparing the team for airway management in a patient with PDA
- Preparing the patient with a PDA for success with airway management
- Performing tracheal intubation
- Post-intubation care
- 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. The steering committee 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
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Airway management experts | – | Other: Delphi procedureThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Clinical expertise in the airway management of critically ill patients
- Teaching experience in airway management
- Research projects and/or publications in airway management
Key exclusion criteria (1 listed)
- People don't meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delphi procedureThe 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. | Other | Airway management experts |
Primary outcome
Consensus statements
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Results publication: PubMed 26759664Mosier 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.
- Results publication: PubMed 35165233Myatra 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.
- Results publication: PubMed 33755076Russotto 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.
- Results publication: PubMed 34153007Karamchandani 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.
- Results publication: PubMed 33060492Kornas 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.
- Results publication: PubMed 24581294Diamond 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.
- Results publication: PubMed 34322364Nasa 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kunal Karamchandani, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation; Difficult or Failed and Intubation Complication, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consensus statements (time frame: Through study completion, an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05762068, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.