Actively Recruiting

Age: 18Years +
All Genders
ID05759299

International observational study on airway management in operating room and non-operating room anesthesia

Led by University of Turin, Italy · Updated on 2025-01-20

10500

Participants Needed

10

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a large international observational study to understand the current rates of major adverse events during advanced airway management in adult patients receiving general anesthesia. This study focuses on patients having elective or emergency surgery both inside operating rooms and in non-operating room settings. It aims to assess serious problems such as cardiovascular collapse, severe low oxygen levels, and cardiac arrest that can occur around the time of intubation, especially when airway management is difficult. The study also seeks to observe worldwide airway management practices during anesthesia. The study will include adults aged 18 and older undergoing advanced airway management, which involves techniques like tracheal intubation or supraglottic airway insertion after anesthesia induction with hypnotic or opioid drugs. Data will be collected on various aspects such as patient details, surgical setting, airway evaluation, monitoring, drug use, laryngoscopy methods, intubation attempts, and complications. Each participating center will enroll up to 50 consecutive eligible patients. Participants will be monitored from anesthesia induction through 30 minutes after for major adverse events including severe hypoxia, cardiovascular collapse, and cardiac arrest. Researchers will also track minor complications, ventilation difficulties, and first pass intubation success rates. Study data includes detailed airway management procedures, patient parameters, and any complications. The involvement lasts around the surgical anesthesia period, providing a comprehensive view of airway management safety and current practices worldwide.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older
  • Undergoing advanced airway management for general anesthesia
  • Procedures performed in operating room or non-operating room anesthesia settings
  • Includes both elective and emergency surgeries
Not Eligible

You will not qualify if you...

  • Airway management during cardiopulmonary resuscitation
  • Critically ill patients undergoing intubation due to their underlying clinical condition

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 30 minutes from induction

Participants undergoing advanced airway management for general anesthesia in operating room or non-operating room settings are observed for major and minor peri-intubation adverse events occurring within 30 minutes from induction.

1 observation period during anesthesia procedure

Trial Site Locations

Total: 10 locations

1

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Not Yet Recruiting

2

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Not Yet Recruiting

3

Cochin University Hospital, Assistance Publique - Hôpitaux de Paris

Paris, France

Actively Recruiting

4

Tata Memorial Hospital

Mumbai, India

Not Yet Recruiting

5

University Hospital of Galway

Galway, Ireland

Not Yet Recruiting

6

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza E Brianza, Italy

Not Yet Recruiting

7

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano, TO, Italy

Not Yet Recruiting

8

A.O.U. Città della Salute e della Scienza

Torino, TO, Italy

Actively Recruiting

9

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Completed

10

Ospedale Santa Chiara, APSS Trento

Trento, Italy

Actively Recruiting

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Research Team

V

Vincenzo Russotto, MD

F

Francesca Collino, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia.

T M Cook, N Woodall, C Frerk...

https://pubmed.ncbi.nlm.nih.gov/21447488

Peri-intubation Cardiovascular Collapse in Patients Who Are Critically Ill: Insights from the INTUBE Study.

Vincenzo Russotto, Elena Tassistro, Sheila N Myatra...

https://pubmed.ncbi.nlm.nih.gov/35536310