International Observational Study on Airway Management in Critically Ill Patients

NCT03616054 | Completed

• 1 other identifier: INTUBE
• Study Type: observational
• Target: 3,600
• Locations: 1 country
• Sites: 1

Brief Summary

Endotracheal intubation (ETI) is a potentially life-threatening procedure for critically ill patients and major severe complications such as severe hypoxia, cardiovascular collapse and cardiac arrest are common. Despite the high risk of the procedure, different interventions lack high-quality evidence and the investigators hypothesize that a heterogeneous practice among different centres and geographical areas may be found. The investigators designed a large international observational study aiming at prospectively collecting data on the current impact of ETI-related adverse events and current airway management practice in critically ill patients. Investigators will collect data on all consecutive in-hospital (intensive care unit, emergency department and wards) ETIs performed in adult critically patients.

Conditions

Critical Illness; Respiratory Failure; Hemodynamic Instability; Coma

Keywords

Airway management

Outcome Measures

Primary Outcomes (1)

• Major intubation-related complication

  At least one of the following (composite outcome): * Severe hypoxemia (SpO2 \< 80%) occurring within 30 minutes from intubation * Cardiac arrest occurring within 30 minutes from intubation * Cardiovascular collapse (at least one of the following), occurring within 30 minutes from intubation: * Systolic arterial pressure \< 65 mmHg recorded 1 time * SAP \< 90 mmHg for \> 30 minutes * New need of vasopressors/their increase and/or fluid load \> 15 ml/kg to maintain the target blood pressure.

  30 minutes

Secondary Outcomes (10)

• Cardiac arrhythmia

  30 minutes

• Difficult intubation

  30 minutes

• Cannot intubate cannot oxygenate scenario (CICO)

  30 minutes

• Emergency front of neck airway (FONA)

  30 minutes

• Aspiration of gastric contents

  24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will include all adult (≥ 18 years old) critically ill patients undergoing intubation during the period of observation. We will consider all in-hospital intubations. We will define critically ill those patients with a life-threatening condition requiring intubation for either cardiorespiratory failure or airway protection.

You may qualify if:

• Critically ill patients undergoing in-hospital endotracheal intubation.

You may not qualify if:

• Intubation performed in the out-of-hospital setting;
• Intubation during cardiac arrest;
• Intubation performed only for anaesthesia.

Sponsors & Collaborators

• Azienda Ospedaliera San Gerardo di Monza: lead

Study Sites (1)

ASST Monza - University Hospital San Gerardo

Monza, Italy

Location

Related Publications (3)

• Russotto V, Laffey JG, Tassistro E, Myatra SN, Rezoagli E, Foti G, Antolini L, Valsecchi MG, Bauer PR, Szuldrzynski K, Camporota L, Greif R, Higgs A, Parotto M, Fumagalli R, Sorbello M, Robba C, Grasselli G, Bellani G, Caironi P, Lascarrou JB; INTUBE Study Investigators. Peri-intubation complications in critically ill obese patients: a secondary analysis of the international INTUBE cohort. Crit Care. 2025 May 13;29(1):192. doi: 10.1186/s13054-025-05419-2.

  PMID: 40361245 DERIVED

• Russotto V, Lascarrou JB, Tassistro E, Parotto M, Antolini L, Bauer P, Szuldrzynski K, Camporota L, Putensen C, Pelosi P, Sorbello M, Higgs A, Greif R, Grasselli G, Valsecchi MG, Fumagalli R, Foti G, Caironi P, Bellani G, Laffey JG, Myatra SN; INTUBE Study Investigators. Efficacy and adverse events profile of videolaryngoscopy in critically ill patients: subanalysis of the INTUBE study. Br J Anaesth. 2023 Sep;131(3):607-616. doi: 10.1016/j.bja.2023.04.022. Epub 2023 May 17.

  PMID: 37208282 DERIVED

• Russotto V, Tassistro E, Myatra SN, Parotto M, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Putensen C, Pelosi P, Sorbello M, Higgs A, Greif R, Pesenti A, Valsecchi MG, Fumagalli R, Foti G, Bellani G, Laffey JG. Peri-intubation Cardiovascular Collapse in Patients Who Are Critically Ill: Insights from the INTUBE Study. Am J Respir Crit Care Med. 2022 Aug 15;206(4):449-458. doi: 10.1164/rccm.202111-2575OC.

  PMID: 35536310 DERIVED

MeSH Terms

Conditions

Critical Illness; Respiratory Insufficiency; Coma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Vincenzo Russotto, MD

  Department of Emergency and Intensive Care, University Hospital San Gerardo Monza, ASST Monza, Monza, Italy

  PRINCIPAL INVESTIGATOR

• Giacomo Bellani, MD, PhD

  Department of Emergency and Intensive Care, University Hospital San Gerardo Monza, ASST Monza, Monza, Italy; University of Milano Bicocca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 15, 2018
• First Posted: August 6, 2018
• Study Start: October 1, 2018
• Primary Completion: July 31, 2019
• Study Completion: September 30, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

IT (1)