An observational study in Neoplasms, Airway Obstruction Upper and Intubation, Intratracheal, sponsored by Onco Critical Care Society. Enrolling by invitation at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Onco Critical Care Society · Observational
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.
BACKGROUND
Failure of airway management causes hypoxaemic brain injury and death within minutes. Outside the operating theatre, tracheal intubation carries a substantially higher rate of severe complications, including cardiovascular collapse and cardiac arrest, than intubation under elective conditions. In patients with cancer this baseline risk is compounded by disease- and treatment-related factors: anatomical distortion by head, neck, or mediastinal tumour; airway and facial oedema from superior vena cava obstruction; mucosal friability and bleeding risk from thrombocytopenia; restricted neck mobility from radiation fibrosis; and supraglottic or glottic stenosis. National audits of airway complications repeatedly identify head and neck pathology and obstructive airway lesions among the recurring contributors to death and brain damage, yet patients with cancer fall outside the population addressed in detail by existing airway guidance.
Several features distinguish this population. Anatomical distortion is acquired, progressive, and often occult, so that an assessment made weeks earlier may not describe the airway encountered. Anterior mediastinal masses can precipitate cardiorespiratory collapse on induction through loss of the negative intrathoracic pressure maintaining airway patency and venous return. Prior radiotherapy raises the likelihood of difficult laryngoscopy, failed facemask ventilation, and difficult surgical access simultaneously, removing the redundancy on which conventional algorithms depend. Where extrinsic compression or oedema is present, a supraglottic airway may fail to seal, so that the principal rescue device of every published algorithm is unreliable in exactly the patients most likely to need it. In malignant central airway obstruction the pathology may lie distal to the tube tip, making rigid bronchoscopy, stenting, or debulking the definitive intervention rather than an adjunct.
Randomised evidence on these questions does not exist and is unlikely to be generated, since the events are uncommon, the situations emergent, and equipoise difficult to sustain. Formal consensus methods are therefore the appropriate means of structuring expert judgement.
OBJECTIVES
The primary objective is to develop an international consensus statement providing explicit criteria and a procedural framework for the prediction, preparation, and management of the difficult airway in adults with cancer, across the settings in which such airways are encountered.
Secondary objectives are to specify an oncology-specific airway assessment and preparation approach; to provide recommendations on pharmacological strategy including induction agents and neuromuscular blockade; to outline a tiered approach to primary airway management and rescue including videolaryngoscopy, awake technique, flexible and rigid bronchoscopy, and front-of-neck access in the irradiated neck; to address malignant central airway obstruction as a distinct entity; to address extubation, tracheostomy decannulation, post-procedural care, and system-level preparedness, training, human factors, and documentation; and to publish the questions on which the panel finds insufficient evidence or fails to agree as a prioritised research agenda.
DOMAINS
Candidate statements are grouped into ten pre-specified domains: (1) oncology-specific airway assessment and risk prediction; (2) pre-procedural preparation and multidisciplinary coordination; (3) pre-oxygenation and peri-procedural oxygenation; (4) pharmacological optimisation; (5) primary airway management devices and approaches; (6) management of malignant central airway obstruction; (7) rescue strategies and front-of-neck access; (8) extubation and tracheostomy decannulation; (9) post-procedural care and follow-up; (10) system preparedness, training, human factors, and documentation.
METHODS
A Steering Committee of 10 to 12 members … [full text copies via the button]
ANALYSIS
Quantitative responses are summarised as counts and percentages … Consensus requires a median of 5 or above with at least 75 percent of votes in the 5 to 7 range …
REPORTING
Reporting follows the ACCORD reporting guideline for consensus methods in biomedicine, with a completed checklist accompanying submission.
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This study's planned enrollment of 40 is below the median of 200 across 2,638 observational studies indexed under Neoplasms.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
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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
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.
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.
Time frame: Through study completion, an average of 4 months
Proportion of statements achieving strong consensus
The percentage of statements meeting the a priori definition of strong consensus, namely a median of 6 or 7 with at least 75 percent of respondents rating the statement 6 to 7, or a median of 1 or 2 with at least 75 percent rating it 1 to 3.
Time frame: Through study completion, an average of 4 months
Stability of panel responses between consecutive rounds
For each statement, the distribution of responses is compared between two consecutive rounds after collapsing into three ordered categories (1 to 3, 4, and 5 to 7), using a non-parametric chi-square test, with the Fisher exact test substituted where expected cell counts fall below five. A p value below 0.05 indicates instability. The number and percentage of statements demonstrating stability is reported.
Time frame: Up to 16 weeks from study start
Number of statements identified as lacking consensus and forming the research agenda
The count and content of statements that fail to reach the a priori consensus threshold after the final round, reported with their response distributions and a synthesis of the arguments advanced on each side, constituting a prioritised research agenda for airway management in oncology.
Time frame: Through study completion, an average of 4 months
Plan to share: Yes — Anonymised, de-identified round-by-round response data will be made available to qualified researchers on reasonable request to the corresponding author, subject to institutional approval and to a data-sharing agreement. Individual panellists will not be identifiable, and the participant key linking responses to individuals will be destroyed once the collaborative author group has been finalised. Free-text comments will be screened for self-identifying content before release. The full Round 1 survey instrument, the domain structure, the evidence summaries, and the completed ACCORD checklist will be published as supplementary material alongside the primary manuscript.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 12 months after publication of the primary manuscript, with no end date.
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