ASST Monza - University Hospital San Gerardo
Monza, Italy
NCT Number: NCT03616054
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Monza, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 30 minutes
At least one of the following (composite outcome):
Time frame: 30 minutes
New onset of any supraventricular or ventricular arrhythmia
Time frame: 30 minutes
> 2 laryngoscopic attempts
Time frame: 30 minutes
'Oxygenation' cannot be achieved using the anatomical conduits of the upper airway
Time frame: 30 minutes
Cricothyroidotomy, percutaneous tracheostomy, surgical tracheostomy
Time frame: 24 hours
Inhalation of oro-pharyngeal or gastric contents into the larynx and the respiratory tract
Time frame: 30 minutes
Accidental placement of endotracheal tube into the oesophagus
Time frame: 24 hours
Pleural/mediastinal air collection attributable to traumatic airway management
Time frame: 24 hours
Any notable change to the patient's dentition attributable to the procedure of endotracheal intubation
Time frame: 24 hours
Any detectable/clinically relevant airways injury attributable to the endotracheal intubation procedure (e.g.bleeding, tracheal tear/laceration)
Time frame: up to 12 weeks
Survival status at ICU discharge
Azienda Ospedaliera San Gerardo di Monza
Other
INternational Observational Study To Understand the Impact and BEst Practices of Airway Management in Critically Ill Patients
Acronym: INTUBE
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.
Published trials that share one or more normalized conditions with this study.
NCT01973829
Bleeding, Coma
Homyel, Belarus
View Trial DetailsNCT02039297
Bleeding, Coma
Scottsdale, Arizona, United States
View Trial DetailsNCT07411976
Critical Illness, Disease Attributes
Nîmes, France
View Trial DetailsNCT07658131
Critical Illness, Disease Attributes
Taichung, Taiwan
View Trial Details