International Observational Study on Airway Management in Critically Ill Patients (INTUBE)

INternational Observational Study To Understand the Impact and BEst Practices of Airway Management in Critically Ill Patients

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Respiratory Failure; Coma; Hemodynamic Instability

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.

• Study Type: Observational
• Enrollment (Actual): 3600

Contacts and Locations

Study Locations

• Italy
  • Monza, Italy
    • ASST Monza - University Hospital San Gerardo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 timeSAP < 90 mmHg for > 30 minutesNew need of vasopressors/their increase and/or fluid load > 15 ml/kg to maintain the target blood pressure.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac arrhythmia	New onset of any supraventricular or ventricular arrhythmia	30 minutes
Difficult intubation	> 2 laryngoscopic attempts	30 minutes
Cannot intubate cannot oxygenate scenario (CICO)	'Oxygenation' cannot be achieved using the anatomical conduits of the upper airway	30 minutes
Emergency front of neck airway (FONA)	Cricothyroidotomy, percutaneous tracheostomy, surgical tracheostomy	30 minutes
Aspiration of gastric contents	Inhalation of oro-pharyngeal or gastric contents into the larynx and the respiratory tract	24 hours
Oesophageal intubation	Accidental placement of endotracheal tube into the oesophagus	30 minutes
Pneumothorax/pneumo-mediastinum	Pleural/mediastinal air collection attributable to traumatic airway management	24 hours
Dental injury	Any notable change to the patient's dentition attributable to the procedure of endotracheal intubation	24 hours
Airways injury	Any detectable/clinically relevant airways injury attributable to the endotracheal intubation procedure (e.g.bleeding, tracheal tear/laceration)	24 hours
ICU mortality	Survival status at ICU discharge	up to 12 weeks

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera San Gerardo di Monza
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: July 15, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Airway management
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Respiratory Insufficiency; Critical Illness
• Other Study ID Numbers: INTUBE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No