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NCT05759299 · ClinicalTrials.gov registry record
International obServational sTudy on AiRway manaGement in operAting Room and Non-operaTing Room anaEsthesia
A clinical trial of Airway Complication of Anesthesia, sponsored by University of Turin, Italy.
- Recruiting
- Registry status
- 10,500
- Enrollment target
- 10
- Study locations
NCT05759299: Recruiting study of Airway Complication of Anesthesia, sponsored by University of Turin, Italy.
NCT05759299 is a study of Airway Complication of Anesthesia that is actively recruiting participants, run by University of Turin, Italy. The registered enrollment target is 10,500 participants. The trial reports 10 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05759299, a study of Airway Complication of Anesthesia, is actively recruiting participants, sponsored by University of Turin, Italy.
- RECRUITING
- Registry status
- 10,500 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
Defined as at least one of the following events: * Cardiovascular collapse (at least one of the following): 1. Systolic arterial pressure \< 65 mmHg 2. Systolic arterial pressure \< 90 mmHg for \> 15 minutes 3. New need of vasopressors and/or fluid load \> 15 ml/kg to maintain the target blood pressure * Cardiac arrest * Severe hypoxemia (SpO2 \< 80%)
Conditions Studied
Interventions
- PROCEDURE Advanced airway management
Study Locations (10)
Other
- Cochin University Hospital, Assistance Publique - Hôpitaux de Paris - Paris
- Tata Memorial Hospital - Mumbai
- University Hospital of Galway - Galway
- ASST Grande Ospedale Metropolitano Niguarda - Milan
- Ospedale Santa Chiara, APSS Trento - Trento
Texas
- University of Texas Southwestern Medical Center - Dallas
- MD Anderson Cancer Center - Houston
TO
- Azienda Ospedaliera Universitaria San Luigi Gonzaga - Orbassano
- A.O.U. Città della Salute e della Scienza - Torino
Monza E Brianza
- Fondazione IRCCS San Gerardo dei Tintori - Monza
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,500 participants |
| Start Date | 2024-01-15 |
| Est. Completion | 2025-05 |
What NCT05759299 shows while recruiting
NCT05759299 is an observational study that tracks outcomes without assigning an intervention. Its 10,500 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Airway Complication of Anesthesia appearing as the primary indexed condition, and to 1 intervention - of which Advanced airway management is the first listed.
NCT05759299 lists 10 locations in 4 states (Other, Texas, TO).
Frequently Asked Questions
What is clinical trial NCT05759299 about?
NCT05759299 is a clinical study titled "International obServational sTudy on AiRway manaGement in operAting Room and Non-operaTing Room anaEsthesia". 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...
What is the current status of trial NCT05759299?
This trial is currently recruiting. The enrollment target is 10,500 participants. The study started on 2024-01-15. Estimated completion is 2025-05.
What conditions does trial NCT05759299 study?
This clinical trial studies the following conditions: Airway Complication of Anesthesia.
What interventions are being tested in trial NCT05759299?
The interventions under investigation include: Advanced airway management (PROCEDURE).
Who is sponsoring clinical trial NCT05759299?
This trial is sponsored by University of Turin, Italy, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05759299 being conducted?
This trial has 10 study locations across Texas, Monza E Brianza, TO. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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