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

NCT05759299 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10500

Last updated 2025-01-20

No results posted yet for this study

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.

Conditions

  • Airway Complication of Anesthesia

Interventions

PROCEDURE

Advanced airway management

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

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Vincenzo Russotto, MD · University of Turin, Italy

  • Francesca Collino, MD · University of Turin, Italy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2025-04-30
Completion
2025-05-31

Countries

  • United States
  • France
  • India
  • Ireland
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05759299 on ClinicalTrials.gov