Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05759299 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: STARGATE
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 20, 2025 (before its estimated April 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Trial status: Not Yet Recruiting to Recruitingv5 Show 7 more changesShow less
    • Primary completion date: Dec 2024 to Apr 2025
    • Study completion date: Dec 2024 to May 2025
    • Start date changed from estimate of Dec 2023 to Jan 15, 2024
    • Interventions: Tracheal intubation (Procedure) to Advanced airway management (Procedure)
    • Site details revised at 10 of 10 sites
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 5 words
  2. Minor Study sites: 0 to 10v4
  3. Notable Primary completion date: May 2024 to Dec 2024
    • Start date: May 2023 to Dec 2023
    • Study completion date: Jun 2024 to Dec 2024
    • Study description shortened, about 1 word
    v3
  4. Minor Study description expanded, about 169 wordsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05759299
Lead Sponsor University of Turin, Italy
Conditions
(from sponsor)
Airway Complication of Anesthesia
Enrollment 10,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov