International Observational Study on Airway Management in Critically Ill Patients (INTUBE)
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|ClinicalTrials.gov Identifier: NCT03616054|
Recruitment Status : Not yet recruiting
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
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|
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.
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.
- Intubation performed in the out-of-hospital setting
- Intubation during cardiac arrest
- Intubation performed for anaesthesia
Major ETI-related adverse events - composite outcome (severe hypoxemia, cardiac arrest and cardiovascular collapse - see further for definitions)
Minor ETI-related adverse events and ICU mortality (see further for definitions).
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|
|Estimated Enrollment :||3600 participants|
|Official Title:||INternational Observational Study To Understand the Impact and BEst Practices of Airway Management in Critically Ill Patients|
|Estimated Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||May 31, 2019|
- 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.
- Cardiac arrhythmia [ Time Frame: 30 minutes ]New onset of any supraventricular or ventricular arrhythmia
- Difficult intubation [ Time Frame: 30 minutes ]> 2 laryngoscopic attempts
- Cannot intubate cannot oxygenate scenario (CICO) [ Time Frame: 30 minutes ]'Oxygenation' cannot be achieved using the anatomical conduits of the upper airway
- Emergency front of neck airway (FONA) [ Time Frame: 30 minutes ]Cricothyroidotomy, percutaneous tracheostomy, surgical tracheostomy
- Aspiration of gastric contents [ Time Frame: 24 hours ]Inhalation of oro-pharyngeal or gastric contents into the larynx and the respiratory tract
- Oesophageal intubation [ Time Frame: 30 minutes ]Accidental placement of endotracheal tube into the oesophagus
- Pneumothorax/pneumo-mediastinum [ Time Frame: 24 hours ]Pleural/mediastinal air collection attributable to traumatic airway management
- Dental injury [ Time Frame: 24 hours ]Any notable change to the patient's dentition attributable to the procedure of endotracheal intubation
- Airways injury [ Time Frame: 24 hours ]Any detectable/clinically relevant airways injury attributable to the endotracheal intubation procedure (e.g.bleeding, tracheal tear/laceration)
- ICU mortality [ Time Frame: up to 12 weeks ]Survival status at ICU discharge
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
|Contact: Vincenzo Russotto, MDemail@example.com|
|Contact: Giacomo Bellani, MD, PhD||+39 039 firstname.lastname@example.org|
|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|