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

Study Overview
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Brief Summary
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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 peri-intubation adverse events during 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
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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 peri-intubation adverse events during 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 intubation 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 intubation 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.

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

Conditions
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Airway Complication of Anesthesia

Intervention / Treatment
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* Procedure: Tracheal intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult (≥ 18 years old) patients undergoing intubation 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing anesthesia in operating room and outside operating room<br>Patients undergoing elective or emergency tracheal intubation to receive general anesthesia for surgery in operating room or outside operating room (e.g. endoscopy and radiology unit, cardiology lab cath) | Procedure: Tracheal intubation<br>* Advanced airway management with tracheal intubation performed after induction with hypnotic and/or opioid drugs and laryngoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major peri-intubation adverse event | Defined as at least one of the following events: Cardiovascular collapse (at least one of the following): Systolic arterial pressure < 65 mmHg Systolic arterial pressure < 90 mmHg for > 15 minutes New need of vasopressors and/or fluid load > 15 ml/kg to maintain the target blood pressure Cardiac arrest Severe hypoxemia (SpO2 < 80%) | 30 minutes from induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 minutes from induction | 
| 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 | 30 minutes from induction | 
| First pass success rate | Incidence of successful intubation after a single attempt of laryngoscopy | 30 minutes from induction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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airway management, anesthesia