International Consensus Statement on Difficult Airway Management in Oncology (DAMO): Protocol for a Modified Delphi Consensus Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of candidate statements achieving consensus
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Proportion of candidate statements achieving consensus
时间窗: 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 80 percent of respondents rating the statement 5 to 7, or a median of 3 or below with at least 80 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.
次要结局
- 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)
研究者
Saurabh Kumar Das
Additional Director, Department of Critical Care
Max Super Speciality Hospital