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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.
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
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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| Measure | Description | Time Frame |
|---|---|---|
| Major intubation-related complication | At least one of the following (composite outcome):
| 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac arrhythmia | New onset of any supraventricular or ventricular arrhythmia | 30 minutes |
| Difficult intubation | > 2 laryngoscopic attempts |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST Monza - University Hospital San Gerardo | Monza | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40361245 | Derived | Russotto V, Laffey JG, Tassistro E, Myatra SN, Rezoagli E, Foti G, Antolini L, Valsecchi MG, Bauer PR, Szuldrzynski K, Camporota L, Greif R, Higgs A, Parotto M, Fumagalli R, Sorbello M, Robba C, Grasselli G, Bellani G, Caironi P, Lascarrou JB; INTUBE Study Investigators. Peri-intubation complications in critically ill obese patients: a secondary analysis of the international INTUBE cohort. Crit Care. 2025 May 13;29(1):192. doi: 10.1186/s13054-025-05419-2. | |
| 37208282 |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D012131 | Respiratory Insufficiency |
| D003128 | Coma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
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| 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 |
| Derived |
| Russotto V, Lascarrou JB, Tassistro E, Parotto M, Antolini L, Bauer P, Szuldrzynski K, Camporota L, Putensen C, Pelosi P, Sorbello M, Higgs A, Greif R, Grasselli G, Valsecchi MG, Fumagalli R, Foti G, Caironi P, Bellani G, Laffey JG, Myatra SN; INTUBE Study Investigators. Efficacy and adverse events profile of videolaryngoscopy in critically ill patients: subanalysis of the INTUBE study. Br J Anaesth. 2023 Sep;131(3):607-616. doi: 10.1016/j.bja.2023.04.022. Epub 2023 May 17. |
| 35536310 | Derived | 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. |
| D012140 | Respiratory Tract Diseases |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |