Difficult Airway Management in Oncology: An International Delphi Consensus Study (DAMO)

NCT07822815 | Enrolling By Invitation

• 1 other identifier: ONCOCCS-DAMO
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Airway management in patients with cancer carries risks that general difficult-airway guidelines do not address. Tumour in the head, neck, or mediastinum can distort or narrow the airway; previous radiotherapy causes fibrosis and restricts neck movement; low platelet counts increase bleeding during instrumentation; and obstruction may sit below the point at which a breathing tube ends, so that intubation alone does not restore ventilation. Existing international airway guidelines are written for general populations and contain little cancer-specific guidance. This study uses a modified Delphi method to develop an international expert consensus statement on the prediction, preparation for, and management of the difficult airway in adults with cancer. An international panel of clinicians with expertise in anaesthesiology, intensive care, interventional pulmonology, head and neck surgery, and emergency medicine votes anonymously on a set of candidate statements across ten clinical domains, using a seven-point agreement scale with free-text comment. Voting takes place over a minimum of three rounds. Between rounds, panellists receive anonymised group results and a summary of comments, and statements are revised accordingly. Consensus is defined a priori as agreement by at least 80 percent of respondents together with a median score of 5 or above; strong consensus requires at least 90 percent agreement with a median of 6 or 7. Statements that do not reach consensus are reported as such and form a prioritised research agenda. Reporting follows the ACCORD reporting guideline for consensus methods.

Conditions

Neoplasms; Intubation, Intratracheal; Head and Neck Neoplasms; Airway Management; Airway Obstruction Upper; Mediastinal Neoplasms

Keywords

Delphi technique; consensus; difficult airway; oncology; onco-critical care; videolaryngoscopy; front-of-neck access; malignant central airway obstruction; rigid bronchoscopy; tracheostomy; extubation; anterior mediastinal mass

Outcome Measures

Primary Outcomes (1)

• Proportion of candidate statements achieving consensus

  The percentage of candidate statements meeting the a priori definition of consensus, namely a median rating of 5 or above with at least 75 percent of respondents rating the statement 5 to 7, or a median of 3 or below with at least 75 percent rating it 1 to 3, sustained across two consecutive rounds. Ratings of 4 are included in the denominator. Abstentions are excluded from the denominator and reported separately.

  Through study completion, an average of 4 months

Secondary Outcomes (3)

• Proportion of statements achieving strong consensus

  Through study completion, an average of 4 months

• Stability of panel responses between consecutive rounds

  Up to 16 weeks from study start

• Number of statements identified as lacking consensus and forming the research agenda

  Through study completion, an average of 4 months

Study Arms (1)

International expert Delphi panel

An international panel of clinicians with expertise in airway management in patients with cancer, drawn from anaesthesiology, intensive care medicine, interventional pulmonology, head and neck surgery, and emergency medicine, and representing multiple World Health Organization regions and both high-income and low- or middle-income health systems. Panellists complete a minimum of three rounds of anonymous electronic questionnaires, rating candidate statements on a seven-point Likert scale with accompanying free-text comment. Between rounds they receive anonymised group response distributions, medians and interquartile ranges, a thematic synthesis of comments, and a side-by-side display of any revised statement wording.

Other: Questionnaire Administration

Interventions

Questionnaire Administration OTHER

Panellists complete a minimum of three rounds of anonymous electronic questionnaires covering ten clinical domains of difficult airway management in patients with cancer. Each statement is rated on a seven-point Likert scale from 1 (strongly disagree) to 7 (strongly agree), with an optional free-text field that becomes mandatory for any rating of 1 to 3. Each round remains open for a minimum of three weeks, with up to two reminders. No clinical intervention is administered to any patient and no patient-identifiable data are collected.

International expert Delphi panel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Practicing clinicians with recognized expertise in airway management in patients with cancer, drawn from anesthesiology, intensive care medicine, interventional pulmonology, head and neck surgery, and emergency medicine. Panellists are identified from author lists of relevant publications and from professional society membership and faculty lists, and are selected to represent multiple World Health Organization regions and both high-income and low- or middle-income health systems. No patients are enrolled and no patient-identifiable data are collected.

You may qualify if:

• Substantial current clinical practice involving airway management in patients with cancer, in anaesthesiology, intensive care medicine, interventional pulmonology, head and neck surgery, or emergency medicine
• At least five years of independent practice following completion of specialist training
• Demonstrated scholarly contribution to the field, evidenced by peer-reviewed publication, invited lecturing, or a leadership role in a relevant professional society or guideline-development body
• Willingness to complete all planned Delphi rounds and to review the final manuscript
• Sufficient written English to complete the survey instrument without translation Membership of the study Steering Committee, whose members do not vote in any round
• Fewer than five years of independent practice following specialist training
• No current clinical practice involving airway management in patients with cancer
• Participation as a pilot tester of the Round 1 instrument, whose responses are excluded from all consensus calculations

Sponsors & Collaborators

• Onco Critical Care Society: lead

Study Sites (1)

Max Super specialty Hospital Shalimar bagh

Delhi, National Capital Territory of Delhi, 110085, India

Location

Related Publications (16)

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  PMID: 28190381 BACKGROUND

• van Zuuren EJ, Logullo P, Price A, Fedorowicz Z, Hughes EL, Gattrell WT. Existing guidance on reporting of consensus methodology: a systematic review to inform ACCORD guideline development. BMJ Open. 2022 Sep 8;12(9):e065154. doi: 10.1136/bmjopen-2022-065154.

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• Ahmad I, El-Boghdadly K, Bhagrath R, Hodzovic I, McNarry AF, Mir F, O'Sullivan EP, Patel A, Stacey M, Vaughan D. Difficult Airway Society guidelines for awake tracheal intubation (ATI) in adults. Anaesthesia. 2020 Apr;75(4):509-528. doi: 10.1111/anae.14904. Epub 2019 Nov 14.

  PMID: 31729018 BACKGROUND

• Higgs A, McGrath BA, Goddard C, Rangasami J, Suntharalingam G, Gale R, Cook TM; Difficult Airway Society; Intensive Care Society; Faculty of Intensive Care Medicine; Royal College of Anaesthetists. Guidelines for the management of tracheal intubation in critically ill adults. Br J Anaesth. 2018 Feb;120(2):323-352. doi: 10.1016/j.bja.2017.10.021. Epub 2017 Nov 26.

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• Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.

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MeSH Terms

Conditions

Neoplasms; Head and Neck Neoplasms; Mediastinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Thoracic Neoplasms; Mediastinal Diseases; Thoracic Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Director, Department of Critical Care

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 16, 2026
• Study Start: August 19, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 12 months after publication of the primary manuscript, with no end date.

Locations

IN (1)