RecruitingNCT05759299

International obServational sTudy on AiRway manaGement in operAting Room and Non-operaTing Room anaEsthesia


Sponsor

University of Turin, Italy

Enrollment

10,500 participants

Start Date

Jan 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

According to WHO, more than 230 million major surgical procedures are carried out under general anaesthesia each year worldwide. Despite important technological advances, airway management remains a major challenge in anaesthesiology. Data from large perspective studies on current incidence of major peri-intubation adverse events are lacking in the anaesthesia setting, especially on outcomes such as peri-intubation cardiovascular collapse, severe hypoxemia, and cardiac arrest. These events are more common in case of difficulties with airway management so that first pass intubation failure significantly increase the risks. Moreover, it has been documented that even transient hypotension during general anaesthesia, may have long-term consequences and may be associated with a worse outcome in patients undergoing non-cardiac surgery. The primary aim of the study is to assess the current incidence of major adverse events during advanced airway management for anaesthesia in patients undergoing elective or emergency surgery and in the setting of nonoperating room anesthesia. The secondary aim is to assess the current practice of airway management during anesthesia worldwide. STARGATE Study will be a large international observational study recruiting all consecutive adult (≥ 18 years old) patients undergoing general anesthesia in operating room and outside operating room. Primary outcome will be a composite of cardiovascular collapse, cardiac arrest and severe hypoxemia.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an international observational study — called STARGATE — that is collecting detailed data on how anesthesiologists manage breathing tubes and advanced airways in both operating rooms and non-operating room settings (like radiology suites or ICUs). Securing a patient's airway during general anesthesia is one of the most critical and potentially risky moments of any procedure, but practices vary considerably between hospitals and countries. This study aims to document what techniques are used, how often complications occur, and what factors are associated with better outcomes. To be eligible, you must be an adult patient (18 years or older) undergoing advanced airway management for general anesthesia. The study covers a broad range of surgical and procedural settings. Patients whose airways are being managed during cardiac arrest (CPR) or critically ill patients being intubated in the ICU solely due to their illness rather than for a procedure are excluded. There is no extra treatment involved — the study simply observes and records what already happens during standard care. Patients (or their representatives) consent to the collection and use of their clinical data. Understanding the landscape of airway management practices worldwide is important for identifying best practices, reducing complications, and improving anesthesia safety training — ultimately protecting patients in one of the most vulnerable moments of any medical procedure.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAdvanced airway management

Advanced airway management with either tracheal intubation or supraglottic airways performed after induction with hypnotic and/or opioid drugs


Locations(10)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Cochin University Hospital, Assistance Publique - Hôpitaux de Paris

Paris, France

Tata Memorial Hospital

Mumbai, India

University Hospital of Galway

Galway, Ireland

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza E Brianza, Italy

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano, TO, Italy

A.O.U. Città della Salute e della Scienza

Torino, TO, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Ospedale Santa Chiara, APSS Trento

Trento, Italy

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NCT05759299


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