About this trial
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
This trial does not accept healthy volunteersQualifiers
All adult (≥ 18 years old) patients undergoing advanced airway management for general anaesthesia in operating room (OR) or non-operating room anaesthesia (NORA).
Disqualifiers
Airway management during cardiopulmonary resuscitation.
Critically ill patients undergoing intubation due to their underlying clinical condition
Trial population
Adult, not critically ill patients, undergoing advanced airway management (i.e. tracheal intubation or supraglottic airways) to receive surgery or any kind of diagnostic or therapeutic procedure under general anesthesia
Trial design
Cohort
Prospective
Treatments tested in this trial
Advanced airway management
Procedure/SurgeryAdvanced airway management with either tracheal intubation or supraglottic airways performed after induction with hypnotic and/or opioid drugs
Treatment groups
Trial outcomes
Primary outcomes
Major peri-intubation adverse event
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%)
Secondary outcomes
Minor peri-intubation adverse events
At least one of the following: * Moderate hypoxia (SpO2 \< 93%) * Airway injury * Clinically relevant bleeding * Oral aspiration of gastric contents * Dental injury
Difficult facemask ventilation
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
First pass success rate
Incidence of successful intubation after a single attempt of laryngoscopy
Other outcomes
Emergency front of neck access (eFONA)
Emergency need for invasive access to the patient's neck to provide adequate oxygenation (e.g. cricothyroidotomy, percutaneous tracheostomy, surgical tracheostomy).
Cannot intubate cannot oxygenate (CICO)
Impossibility to achieve a successful tracheal intubation and adequate patient's oxygenation
Unplanned need for ICU secondary to airway management complications
Unplanned admission to ICU after an airway-related complication or prolonged/difficult instrumentation
In-hospital mortality
Death during the same hospital admission
Sponsors and contacts
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