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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Turin, Italy

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Advanced airway management

    Procedure/Surgery

    Advanced airway management with either tracheal intubation or supraglottic airways performed after induction with hypnotic and/or opioid drugs

Treatment groups

10,500 Participants
are divided into 1 treatment group
Group A: Patients undergoing anesthesia in operating room and outside operating room1 intervention

Trial outcomes

Primary outcomes

1

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%)

Time frame
30 minutes from induction

Secondary outcomes

1

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

Time frame
30 minutes from induction
2

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

Time frame
30 minutes from induction
3

First pass success rate

Incidence of successful intubation after a single attempt of laryngoscopy

Time frame
30 minutes from induction

Other outcomes

1

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).

Time frame
30 minutes from induction
2

Cannot intubate cannot oxygenate (CICO)

Impossibility to achieve a successful tracheal intubation and adequate patient's oxygenation

Time frame
30 minutes from induction
3

Unplanned need for ICU secondary to airway management complications

Unplanned admission to ICU after an airway-related complication or prolonged/difficult instrumentation

Time frame
24 hours from induction
4

In-hospital mortality

Death during the same hospital admission

Time frame
28 days from induction

Sponsors and contacts

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