Advanced airway management
ProcedureAdvanced airway management with either tracheal intubation or supraglottic airways performed after induction with hypnotic and/or opioid drugs
NCT Number: NCT05759299
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Cochin University Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France
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 anesthesiology. Data from large perspective studies on current incidence of major peri-intubation adverse events are lacking in the anesthesia 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 anesthesia, 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 anesthesia in patients undergoing elective or emergency surgery and in the setting of non-operating room anesthesia. The secondary aim is to assess the current practice of airway management during anesthesia worldwide.
Study design: International, multicenter, prospective cohort study
Inclusion criteria
We will include 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.
Primary outcome: At least one of the following major peri-intubation adverse events occurring within 30 minutes from induction or up to surgical incision: severe hypoxia, cardiovascular collapse, cardiac arrest.
Study duration: All centers will enroll all consecutive patients meeting study criteria up to 50 maximum patients for each center.
Collected data: We will collect the following information:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Advanced airway management with either tracheal intubation or supraglottic airways performed after induction with hypnotic and/or opioid drugs
Time frame: 30 minutes from induction
Defined as at least one of the following events:
Time frame: 30 minutes from induction
At least one of the following:
Time frame: 30 minutes from induction
Impossibility to provide adequate ventilation because of one or more of the following problems: inadequate mask seal, excessive gas leak, or excessive resistance to the ingress or egress of gas
Time frame: 30 minutes from induction
Incidence of successful intubation after a single attempt of laryngoscopy
Time frame: 30 minutes from induction
Emergency need for invasive access to the patient's neck to provide adequate oxygenation (e.g. cricothyroidotomy, percutaneous tracheostomy, surgical tracheostomy).
Time frame: 30 minutes from induction
Impossibility to achieve a successful tracheal intubation and adequate patient's oxygenation
Time frame: 24 hours from induction
Unplanned admission to ICU after an airway-related complication or prolonged/difficult instrumentation
Time frame: 28 days from induction
Death during the same hospital admission
Contact information is provided by the study sponsor or research team.
Francesca Collino, MD
CONTACT
Vincenzo Russotto, MD
CONTACT
University of Turin, Italy
Other
Acronym: STARGATE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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