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RECRUITING
NCT05759299

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

Sponsor: University of Turin, Italy

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

10500

Start Date

2024-01-15

Completion Date

2025-05

Last Updated

2025-01-20

Healthy Volunteers

No

Interventions

PROCEDURE

Advanced 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