More than 300 million major surgical procedures are carried out under general anaesthesia each year worldwide, and advanced airway management remains one of the leading daily challenges for clinicians. Data from large international prospective cohort studies on adverse events such as cardiovascular collapse, cardiac arrest and severe hypoxaemia during advanced airway management to facilitate anaesthesia are lacking.

The International obServational sTudy on AiRway manaGement in operAting room and non-operaTing room anaEsthesia (STARGATE) study will be an international prospective observational cohort study describing the incidence of major adverse events associated with advanced airway management (tracheal intubation or supraglottic airway device placement) for general anaesthesia in the operating and non-operating room for surgery and medical procedures. The secondary aim will be to describe the practice of airway management in a large international cohort. Critically ill patients will be excluded from this study. Data on patients’ characteristics, type of procedure and the adopted airway management strategy, post-procedure adverse events, operator characteristics and in-hospital mortality will be prospectively collected. The study aims to enrol 10 500 patients.

The study has been approved by the Ethics Committee of the coordinating centre (Comitato Etico Interaziendale AOU San Luigi Gonzaga, N° 25/2023). Each of the participating centres will then seek approval of their local Ethics Committee before enrolment. Data will be disseminated to the scientific community by original articles submitted to international peer-reviewed journals.

NCT05759299.

Postoperative pulmonary complications (PPCs) represent a significant cause of postoperative morbidity and even mortality. However, there is a lack of consensus regarding this composite endpoint, the definition of the individual components, classification and optimal outcome measures. This study aims to refine the PPCs composite framework by evaluating its construct validity, assessing the necessity and risks of a composite measure and exploring the feasibility of differentiating severity categories.

A Delphi consensus process will be conducted, engaging an international multidisciplinary group of 30–40 panellists, including clinicians, researchers, patients, public representatives and health economists. Through iterative rounds, the study will seek agreement on the individual components of the PPCs composite. Additionally, consensus will establish a framework for a composite outcome measure based on a standardised severity classification, appropriate timeframes and weighted grading of PPCs.

Consensus, defined by ≥75% concurrence in multiple choice questions or on Likert–scale statements, will be evaluated from round 2 onwards. Delphi rounds will be continued until all statements have reached stability of responses evaluated by ² tests or the Kruskal-Wallis test.

The study will be conducted in strict compliance with the principles of the Declaration of Helsinki and will adhere to ACCORD guidance for reporting. Ethics approval has been obtained for this study from the University of Wolverhampton, UK (SOABE/202425/staff/3). Informed consent will be obtained from all panellists before the commencement of the Delphi process. The results of the study will be published in a peer–reviewed journal with the authorship assigned in accordance with ICMJE requirements.

NCT06916598 (clinicaltrials.gov).