Clinical trial NCT03616054: International Observational Study on Airway Management in Critically Ill Patients
Official title: INternational Observational Study To Understand the Impact and BEst Practices of Airway Management in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Respiratory Failure
Hemodynamic Instability
Coma
Keywords: Airway management
Lead sponsor: Azienda Ospedaliera San Gerardo di Monza
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Major intubation-related complication
timeFrame: 30 minutes
Secondary outcomes:
measure: Cardiac arrhythmia
timeFrame: 30 minutes
measure: Difficult intubation
timeFrame: 30 minutes
measure: Cannot intubate cannot oxygenate scenario (CICO)
timeFrame: 30 minutes
measure: Emergency front of neck airway (FONA)
timeFrame: 30 minutes
measure: Aspiration of gastric contents
timeFrame: 24 hours
measure: Oesophageal intubation
timeFrame: 30 minutes
measure: Pneumothorax/pneumo-mediastinum
timeFrame: 24 hours
measure: Dental injury
timeFrame: 24 hours
measure: Airways injury
timeFrame: 24 hours
measure: ICU mortality
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Monza
country: Italy
facility: ASST Monza - University Hospital San Gerardo
Study officials:
affiliation: Department of Emergency and Intensive Care, University Hospital San Gerardo Monza, ASST Monza, Monza, Italy
name: Vincenzo Russotto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Emergency and Intensive Care, University Hospital San Gerardo Monza, ASST Monza, Monza, Italy; University of Milano Bicocca
name: Giacomo Bellani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.