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

Recruiting now

Conditions studied: Airway Complication of Anesthesia

In brief

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.

Key facts

Study ID

NCT05759299

Run by

University of Turin, Italy

People needed

10500

Starts

2024-01-15

Expected to finish

2025-05-01

Last updated by the study team

2025-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All adult (≥ 18 years old) patients undergoing advanced airway management for general anaesthesia in operating room (OR) or non-operating room anaesthesia (NORA).

You may not qualify if…

• Airway management during cardiopulmonary resuscitation.
• Critically ill patients undergoing intubation due to their underlying clinical condition

Where it is running

• A.O.U. Città della Salute e della Scienza — Torino, TO, Italy (enrolling)
• Cochin University Hospital, Assistance Publique - Hôpitaux de Paris — Paris, France (enrolling)
• Ospedale Santa Chiara, APSS Trento — Trento, Italy (enrolling)
• University Hospital of Galway — Galway, Ireland
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Azienda Ospedaliera Universitaria San Luigi Gonzaga — Orbassano, TO, Italy
• ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy
• Fondazione IRCCS San Gerardo dei Tintori — Monza, Monza E Brianza, Italy
• MD Anderson Cancer Center — Houston, Texas, United States
• Tata Memorial Hospital — Mumbai, India

Full record on ClinicalTrials.gov

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