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Completed

NCT Number: NCT03616054

International Observational Study on 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Major intubation-related complication

    Time frame: 30 minutes

    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.

Secondary outcomes

  1. Cardiac arrhythmia

    Time frame: 30 minutes

    New onset of any supraventricular or ventricular arrhythmia

  2. Difficult intubation

    Time frame: 30 minutes

    > 2 laryngoscopic attempts

  3. Cannot intubate cannot oxygenate scenario (CICO)

    Time frame: 30 minutes

    'Oxygenation' cannot be achieved using the anatomical conduits of the upper airway

  4. Emergency front of neck airway (FONA)

    Time frame: 30 minutes

    Cricothyroidotomy, percutaneous tracheostomy, surgical tracheostomy

  5. Aspiration of gastric contents

    Time frame: 24 hours

    Inhalation of oro-pharyngeal or gastric contents into the larynx and the respiratory tract

  6. Oesophageal intubation

    Time frame: 30 minutes

    Accidental placement of endotracheal tube into the oesophagus

  7. Pneumothorax/pneumo-mediastinum

    Time frame: 24 hours

    Pleural/mediastinal air collection attributable to traumatic airway management

  8. Dental injury

    Time frame: 24 hours

    Any notable change to the patient's dentition attributable to the procedure of endotracheal intubation

  9. Airways injury

    Time frame: 24 hours

    Any detectable/clinically relevant airways injury attributable to the endotracheal intubation procedure (e.g.bleeding, tracheal tear/laceration)

  10. ICU mortality

    Time frame: up to 12 weeks

    Survival status at ICU discharge

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera San Gerardo di Monza

Other

Registry information

Official study title

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

Acronym: INTUBE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 6, 2018
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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