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

Conditions

• Airway Complication of Anesthesia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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 Dates

Start date

Jan 15, 2024

Status verified

Jan 2025

Primary completion

Apr 30, 2025

Completion

May 31, 2025

Study Design

Enrollment

10,500 participants (estimated)

Arms

• Arm: Patients undergoing anesthesia in operating room and outside operating room
  Patients undergoing elective or emergency advanced airway management to receive general anesthesia for surgery in operating room or outside operating room (e.g. endoscopy and radiology unit, cardiology lab cath)

Primary Outcome Measure

Major peri-intubation adverse event [ Time Frame: 30 minutes from induction ]

Central Contacts

• Vincenzo Russotto, MD
  +393297893044
  [email protected]
• Francesca Collino, MD
  +393334320985
  [email protected]

Locations (2)

Find similar trials in Dallas, TX

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