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Trial record 3 of 97 for:    INTUBE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03616054
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Vincenzo Russotto, MD, Azienda Ospedaliera San Gerardo di Monza

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.


Condition or disease
Critical Illness Respiratory Failure Hemodynamic Instability Coma

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.

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Study Type : Observational
Actual Enrollment : 3600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: INternational Observational Study To Understand the Impact and BEst Practices of Airway Management in Critically Ill Patients
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : September 30, 2019



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616054


Locations
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Italy
ASST Monza - University Hospital San Gerardo
Monza, Italy
Sponsors and Collaborators
Azienda Ospedaliera San Gerardo di Monza
Investigators
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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

Additional Information:
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Responsible Party: Vincenzo Russotto, MD, MD, Azienda Ospedaliera San Gerardo di Monza
ClinicalTrials.gov Identifier: NCT03616054    
Other Study ID Numbers: INTUBE
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vincenzo Russotto, MD, Azienda Ospedaliera San Gerardo di Monza:
Airway management
Additional relevant MeSH terms:
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Respiratory Insufficiency
Critical Illness
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases