International Observational Study on Airway Management in Critically Ill Patients

NCT ID: NCT03616054

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-09-30

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.

Detailed Description

This study aims at prospectively collecting data on the current morbidity and mortality of ETI-related adverse events and current airway management practice in adult critically ill patients. Investigators designed a large international study calling for participation all institutions caring critically ill patients worldwide.

Inclusion criteria

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

Exclusion Criteria

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

Primary Outcome

Major ETI-related adverse events - composite outcome (severe hypoxemia, cardiac arrest and cardiovascular collapse - see further for definitions)

Secondary Outcomes

Minor ETI-related adverse events and ICU mortality (see further for definitions).

Sample size

Investigators' aim is to collect data from 1000 intubation- related major complications. From a previously published report (Jaber 2006) the expected incidence of at least one major complication is 28%. Therefore investigators plan to recruit data from 3600 endotracheal intubations. Intubation rate may vary from 0.5 to 2 ETIs/day according to different centres (e.g. total hospital beds, number of ICUs and ICU beds) and local policies. Each centre will be asked to collect data from 20 ETIs. A maximum time window of 8 weeks will be allowed for each centre (i.e. for centres with a slower recruitment rate, data collection will stop after 8 weeks irrespective of total number of ETIs collected data). Investigators plan to recruit at least 180 centres worldwide.

Conditions

Critical Illness; Respiratory Failure; Hemodynamic Instability; Coma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Critically ill patients undergoing in-hospital endotracheal intubation.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera San Gerardo di Monza

OTHER

Sponsor Role: lead

Responsible Party

Vincenzo Russotto, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincenzo Russotto, MD

Role: PRINCIPAL_INVESTIGATOR

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

Giacomo Bellani, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

ASST Monza - University Hospital San Gerardo

Monza, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 40361245 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37208282 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35536310 (View on PubMed)

Other Identifiers

INTUBE

Identifier Type: -

Identifier Source: org_study_id