RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-15
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05759299

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All adult (≥ 18 years old) patients undergoing advanced airway management for general anaesthesia in operating room (OR) or non-operating room anaesthesia (NORA).
  1. * Airway management during cardiopulmonary resuscitation.
  2. * Critically ill patients undergoing intubation due to their underlying clinical condition

Contacts and Locations

Study Contact

Vincenzo Russotto, MD
CONTACT
+393297893044
vincenzo.russotto@unito.it
Francesca Collino, MD
CONTACT
+393334320985
francesca.collino@unito.it

Principal Investigator

Vincenzo Russotto, MD
PRINCIPAL_INVESTIGATOR
University of Turin, Italy
Francesca Collino, MD
PRINCIPAL_INVESTIGATOR
University of Turin, Italy

Study Locations (Sites)

University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: University of Turin, Italy

  • Vincenzo Russotto, MD, PRINCIPAL_INVESTIGATOR, University of Turin, Italy
  • Francesca Collino, MD, PRINCIPAL_INVESTIGATOR, University of Turin, Italy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-15
Study Completion Date2025-05

Study Record Updates

Study Start Date2024-01-15
Study Completion Date2025-05

Terms related to this study

Keywords Provided by Researchers

  • airway management
  • anesthesia

Additional Relevant MeSH Terms

  • Airway Complication of Anesthesia