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International Observational Study on Airway Management in Critically Ill Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03616054
Acronym
INTUBE
Enrollment
3600
Registered
2018-08-06
Start date
2018-10-01
Completion date
2019-09-30
Last updated
2020-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coma, Critical Illness, Hemodynamic Instability, Respiratory Failure

Keywords

Airway management

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.

Interventions

None listed

Sponsors

Azienda Ospedaliera San Gerardo di Monza
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Major intubation-related complication30 minutesAt 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.

Secondary

MeasureTime frameDescription
Difficult intubation30 minutes\> 2 laryngoscopic attempts
Cannot intubate cannot oxygenate scenario (CICO)30 minutes'Oxygenation' cannot be achieved using the anatomical conduits of the upper airway
Emergency front of neck airway (FONA)30 minutesCricothyroidotomy, percutaneous tracheostomy, surgical tracheostomy
Aspiration of gastric contents24 hoursInhalation of oro-pharyngeal or gastric contents into the larynx and the respiratory tract
Cardiac arrhythmia30 minutesNew onset of any supraventricular or ventricular arrhythmia
Pneumothorax/pneumo-mediastinum24 hoursPleural/mediastinal air collection attributable to traumatic airway management
Dental injury24 hoursAny notable change to the patient's dentition attributable to the procedure of endotracheal intubation
Airways injury24 hoursAny detectable/clinically relevant airways injury attributable to the endotracheal intubation procedure (e.g.bleeding, tracheal tear/laceration)
ICU mortalityup to 12 weeksSurvival status at ICU discharge
Oesophageal intubation30 minutesAccidental placement of endotracheal tube into the oesophagus

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026