Clinical trial NCT05759299: International obServational sTudy on AiRway manaGement in operAting Room and Non-operaTing Room anaEsthesia
Official title: International obServational sTudy on AiRway manaGement in operAting Room and Non-operaTing Room anaEsthesia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Airway Complication of Anesthesia
Keywords: airway management
anesthesia
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 10500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Major peri-intubation adverse event
timeFrame: 30 minutes from induction
Secondary outcomes:
measure: Minor peri-intubation adverse events
timeFrame: 30 minutes from induction
measure: Difficult facemask ventilation
timeFrame: 30 minutes from induction
measure: First pass success rate
timeFrame: 30 minutes from induction
Other outcomes:
measure: Emergency front of neck access (eFONA)
timeFrame: 30 minutes from induction
measure: Cannot intubate cannot oxygenate (CICO)
timeFrame: 30 minutes from induction
measure: Unplanned need for ICU secondary to airway management complications
timeFrame: 24 hours from induction
measure: In-hospital mortality
timeFrame: 28 days from induction
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Paris
country: France
facility: Cochin University Hospital, Assistance Publique - Hôpitaux de Paris
city: Mumbai
country: India
facility: Tata Memorial Hospital
city: Galway
country: Ireland
facility: University Hospital of Galway
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
state: Monza E Brianza
city: Orbassano
country: Italy
facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga
state: TO
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza
state: TO
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Trento
country: Italy
facility: Ospedale Santa Chiara, APSS Trento
Study officials:
affiliation: University of Turin, Italy
name: Vincenzo Russotto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turin, Italy
name: Francesca Collino, MD
role: PRINCIPAL_INVESTIGATOR
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