NeoplasmsDAMONCT07822815
Difficult Airway Management in Oncology: An International Delphi Consensus Study (DAMO)
An observational study of Neoplasms and Airway Obstruction Upper, run by Onco Critical Care Society at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Airway Obstruction Upper, Intubation, Intratracheal
- What is being tested?
- Questionnaire Administration
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 19 Aug 2026to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Max Super specialty Hospital Shalimar bagh
Delhi, National Capital Territory of Delhi, 110085
About this study
Official title: International Consensus Statement on Difficult Airway Management in Oncology (DAMO): Protocol for a Modified Delphi Consensus Study
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.
Read the detailed description
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.
- Conditions
- Neoplasms, Airway Obstruction Upper, Intubation, Intratracheal, Head and Neck Neoplasms, Mediastinal Neoplasms, Airway Management
- Being tested
- Questionnaire Administration
- 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
- Medical subject headings
- Neoplasms, Head and Neck Neoplasms, Mediastinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 4 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start19 Aug 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onco Critical Care Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saurabh Kumar Das, Max Super Speciality Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822815
- Sponsor's protocol ID
- ONCOCCS-DAMO
- Acronym
- DAMO
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Junger S, Payne SA, Brine J, Radbruch L, Brearley SG. Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: Recommendations based on a methodological systematic review. Palliat Med. 2017 Sep;31(8):684-706. doi: 10.1177/0269216317690685. Epub 2017 Feb 13.
PubMed 28190381van 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.
PubMed 36201247Gattrell WT, Logullo P, van Zuuren EJ, Price A, Hughes EL, Blazey P, Winchester CC, Tovey D, Goldman K, Hungin AP, Harrison N. ACCORD (ACcurate COnsensus Reporting Document): A reporting guideline for consensus methods in biomedicine developed via a modified Delphi. PLoS Med. 2024 Jan 23;21(1):e1004326. doi: 10.1371/journal.pmed.1004326. eCollection 2024 Jan.
PubMed 38261576Diamond 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 34322364Heidegger T, Gerig HJ, Ulrich B, Kreienbuhl G. Validation of a simple algorithm for tracheal intubation: daily practice is the key to success in emergencies--an analysis of 13,248 intubations. Anesth Analg. 2001 Feb;92(2):517-22. doi: 10.1097/00000539-200102000-00044.
PubMed 11159261Ernst A, Feller-Kopman D, Becker HD, Mehta AC. Central airway obstruction. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1278-97. doi: 10.1164/rccm.200210-1181SO.
PubMed 15187010Hillel AT, Karatayli-Ozgursoy S, Samad I, Best SR, Pandian V, Giraldez L, Gross J, Wootten C, Gelbard A, Akst LM, Johns MM; North American Airway Collaborative (NoAAC). Predictors of Posterior Glottic Stenosis: A Multi-Institutional Case-Control Study. Ann Otol Rhinol Laryngol. 2016 Mar;125(3):257-63. doi: 10.1177/0003489415608867. Epub 2015 Oct 14.
PubMed 26466860Blank RS, de Souza DG. Anesthetic management of patients with an anterior mediastinal mass: continuing professional development. Can J Anaesth. 2011 Sep;58(9):853-9, 860-7. doi: 10.1007/s12630-011-9539-x. Epub 2011 Jul 21. English, French.
PubMed 21779948Ahmad 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.
PubMed 31729018Higgs 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.
PubMed 29406182Frerk 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.
PubMed 26556848Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, Fiadjoe JE, Greif R, Klock PA, Mercier D, Myatra SN, O'Sullivan EP, Rosenblatt WH, Sorbello M, Tung A. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022 Jan 1;136(1):31-81. doi: 10.1097/ALN.0000000000004002.
PubMed 34762729Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
PubMed 21447488Mosier 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 26759664
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Consensus Statement on Difficult Airway Management in Oncology (DAMO): Protocol for a Modified Delphi Consensus Study
- ClinicalTrials.gov ID
- NCT07822815
- Acronym / sponsor ID
- DAMO / ONCOCCS-DAMO
- Conditions
- Neoplasms, Airway Obstruction Upper, Intubation, Intratracheal, Head and Neck Neoplasms, Mediastinal Neoplasms, Airway Management
- Keywords
- Delphi technique, consensus, difficult airway, oncology, onco-critical care, videolaryngoscopy, front-of-neck access, malignant central airway obstruction
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Onco Critical Care SocietyUniversity, hospital or other
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 16 Sep 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| International expert Delphi panel | – | Other: Questionnaire AdministrationAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Questionnaire AdministrationPanellists 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. | Other | International expert Delphi panel |
Primary outcome
Proportion of candidate statements achieving consensus
Time frame: Through study completion, an average of 4 months
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.
3 secondary outcomes
Proportion of statements achieving strong consensus
Time frame: Through study completion, an average of 4 months
Stability of panel responses between consecutive rounds
Time frame: Up to 16 weeks from study start
Number of statements identified as lacking consensus and forming the research agenda
Time frame: Through study completion, an average of 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 28190381Junger S, Payne SA, Brine J, Radbruch L, Brearley SG. Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: Recommendations based on a methodological systematic review. Palliat Med. 2017 Sep;31(8):684-706. doi: 10.1177/0269216317690685. Epub 2017 Feb 13.
- Background: PubMed 36201247van 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.
- Background: PubMed 38261576Gattrell WT, Logullo P, van Zuuren EJ, Price A, Hughes EL, Blazey P, Winchester CC, Tovey D, Goldman K, Hungin AP, Harrison N. ACCORD (ACcurate COnsensus Reporting Document): A reporting guideline for consensus methods in biomedicine developed via a modified Delphi. PLoS Med. 2024 Jan 23;21(1):e1004326. doi: 10.1371/journal.pmed.1004326. eCollection 2024 Jan.
- Background: 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.
- Background: 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.
- Background: PubMed 11159261Heidegger T, Gerig HJ, Ulrich B, Kreienbuhl G. Validation of a simple algorithm for tracheal intubation: daily practice is the key to success in emergencies--an analysis of 13,248 intubations. Anesth Analg. 2001 Feb;92(2):517-22. doi: 10.1097/00000539-200102000-00044.
- Background: PubMed 15187010Ernst A, Feller-Kopman D, Becker HD, Mehta AC. Central airway obstruction. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1278-97. doi: 10.1164/rccm.200210-1181SO.
- Background: PubMed 26466860Hillel AT, Karatayli-Ozgursoy S, Samad I, Best SR, Pandian V, Giraldez L, Gross J, Wootten C, Gelbard A, Akst LM, Johns MM; North American Airway Collaborative (NoAAC). Predictors of Posterior Glottic Stenosis: A Multi-Institutional Case-Control Study. Ann Otol Rhinol Laryngol. 2016 Mar;125(3):257-63. doi: 10.1177/0003489415608867. Epub 2015 Oct 14.
- Background: PubMed 21779948Blank RS, de Souza DG. Anesthetic management of patients with an anterior mediastinal mass: continuing professional development. Can J Anaesth. 2011 Sep;58(9):853-9, 860-7. doi: 10.1007/s12630-011-9539-x. Epub 2011 Jul 21. English, French.
- Background: PubMed 31729018Ahmad 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.
- Background: PubMed 29406182Higgs 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.
- Background: PubMed 26556848Frerk 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.
- Individual participant dataSharing planned: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neoplasms and Airway Obstruction Upper, run by Onco Critical Care Society at 1 site in India.
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 8 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: enrolling by invitation, as of the sponsor's last update on 1 Oct 2026. 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 India. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of candidate statements achieving consensus (time frame: Through study completion, an average of 4 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 NCT07822815, which also lists 16 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 1 Oct 2026.