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

University of Turin

Status: Enrolling

Conditions: Airway Complication of Anesthesia

Treatments: Procedure: Advanced airway management

Study type: Observational

Funder types: Other

Identifiers

NCT05759299

STARGATE

Details and patient eligibility

About

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.

Full 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 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:

• Informed consent and admission data
• Demographic and clinical characteristics
• Type of procedure (time, setting, type of surgery, elective or emergency
• Airway evaluation (anticipated difficult airway management)
• Monitoring applied during the procedure
• Patient's parameters
• Preoxygenation method and use of apnoeic oxygenation (position during preoxygenation, rapid sequence induction applied)
• Drugs used for induction (molecules and doses)
• Elective method for laryngoscopy
• Operator's characteristics
• Method used for the second (and following) attempt
• Method used for adequate tube placement confirmation
• Duration of laryngoscopy
• Outcome of endotracheal intubation (total number of attempts, laryngoscopy view, minimum SpO2 during laryngoscopy, need for LMA)
• Intubation-related complications (severe cardiovascular collapse, severe and mild hypoxemia, cardiac arrest, airway injury or any bleeding, aspiration of gastric contents, dental injury, emergency front of neck airway (FONA), cannot intubate cannot oxygenate scenario (CICO), unplanned need for ICU secondary to airway management complications)
• Extubation procedure.

Enrollment: 10,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Trial design

10,500 participants in 1 patient group

Patients undergoing anesthesia in operating room and outside operating room

Description:

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)

Treatment:

Procedure: Advanced airway management