Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05759299

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cochin University Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Advanced airway management

Procedure

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

Primary outcomes

  1. Major peri-intubation adverse event

    Time frame: 30 minutes from induction

    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%)

Secondary outcomes

  1. Minor peri-intubation adverse events

    Time frame: 30 minutes from induction

    At least one of the following:

    • Moderate hypoxia (SpO2 < 93%)
    • Airway injury
    • Clinically relevant bleeding
    • Oral aspiration of gastric contents
    • Dental injury
  2. Difficult facemask ventilation

    Time frame: 30 minutes from induction

    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

  3. First pass success rate

    Time frame: 30 minutes from induction

    Incidence of successful intubation after a single attempt of laryngoscopy

Other outcomes

  1. Emergency front of neck access (eFONA)

    Time frame: 30 minutes from induction

    Emergency need for invasive access to the patient's neck to provide adequate oxygenation (e.g. cricothyroidotomy, percutaneous tracheostomy, surgical tracheostomy).

  2. Cannot intubate cannot oxygenate (CICO)

    Time frame: 30 minutes from induction

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

  3. Unplanned need for ICU secondary to airway management complications

    Time frame: 24 hours from induction

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

  4. In-hospital mortality

    Time frame: 28 days from induction

    Death during the same hospital admission

Study contacts

Contact information is provided by the study sponsor or research team.

Francesca Collino, MD

CONTACT

[email protected]

+393334320985

Vincenzo Russotto, MD

CONTACT

[email protected]

+393297893044

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Acronym: STARGATE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2023
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.