NCT05759299 International obServational sTudy on AiRway manaGement in operAting Room and Non-operaTing Room anaEsthesia
| NCT ID | NCT05759299 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Turin, Italy |
| Condition | Airway Complication of Anesthesia |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,500 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2025-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,500 participants in total. It began in 2024-01-15 with a primary completion date of 2025-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * All adult (≥ 18 years old) patients undergoing advanced airway management for general anaesthesia in operating room (OR) or non-operating room anaesthesia (NORA). Exclusion Criteria: * Airway management during cardiopulmonary resuscitation. * Critically ill patients undergoing intubation due to their underlying clinical condition
Contact & Investigator
Vincenzo Russotto, MD
PRINCIPAL INVESTIGATOR
University of Turin, Italy
Frequently Asked Questions
Who can join the NCT05759299 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Airway Complication of Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05759299 currently recruiting?
Yes, NCT05759299 is actively recruiting participants. Contact the research team at vincenzo.russotto@unito.it for enrollment information.
Where is the NCT05759299 trial being conducted?
This trial is being conducted at Dallas, United States, Houston, United States, Paris, France, Mumbai, India and 6 additional locations.
Who is sponsoring the NCT05759299 clinical trial?
NCT05759299 is sponsored by University of Turin, Italy. The principal investigator is Vincenzo Russotto, MD at University of Turin, Italy. The trial plans to enroll 10,500 participants.