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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• All adult (≥ 18 years old) patients undergoing advanced airway management for general anaesthesia in operating room (OR) or non-operating room anaesthesia (NORA).

Locations
United States
Texas
University of Texas Southwestern Medical Center
NOT_YET_RECRUITING
Dallas
MD Anderson Cancer Center
NOT_YET_RECRUITING
Houston
Other Locations
France
Cochin University Hospital, Assistance Publique - Hôpitaux de Paris
RECRUITING
Paris
India
Tata Memorial Hospital
NOT_YET_RECRUITING
Mumbai
Ireland
University Hospital of Galway
NOT_YET_RECRUITING
Galway
Italy
ASST Grande Ospedale Metropolitano Niguarda
COMPLETED
Milan
Fondazione IRCCS San Gerardo dei Tintori
NOT_YET_RECRUITING
Monza
Azienda Ospedaliera Universitaria San Luigi Gonzaga
NOT_YET_RECRUITING
Orbassano
A.O.U. Città della Salute e della Scienza
RECRUITING
Torino
Ospedale Santa Chiara, APSS Trento
RECRUITING
Trento
Contact Information
Primary
Vincenzo Russotto, MD
vincenzo.russotto@unito.it
+393297893044
Backup
Francesca Collino, MD
francesca.collino@unito.it
+393334320985
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2025-05
Participants
Target number of participants: 10500
Treatments
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)
Sponsors
Leads: University of Turin, Italy

This content was sourced from clinicaltrials.gov