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.
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.
Brief Title
International Observational Study on Airway Management in Critically Ill 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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Critical Illness
Respiratory Failure
Hemodynamic Instability
Coma
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.
* 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.
Inclusion Criteria
Inclusion Criteria:
* Critically ill patients undergoing in-hospital endotracheal intubation.
* Critically ill patients undergoing in-hospital endotracheal intubation.
Gender
All
Gender Based
false
Keywords
Airway management
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03616054
Org Class
Other
Org Full Name
Azienda Ospedaliera San Gerardo di Monza
Org Study Id
INTUBE
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
INternational Observational Study To Understand the Impact and BEst Practices of Airway Management in Critically Ill Patients
Primary Outcomes
Outcome Description
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.
* 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.
Outcome Measure
Major intubation-related complication
Outcome Time Frame
30 minutes
Secondary Outcomes
Outcome Description
New onset of any supraventricular or ventricular arrhythmia
Outcome Time Frame
30 minutes
Outcome Measure
Cardiac arrhythmia
Outcome Description
\> 2 laryngoscopic attempts
Outcome Time Frame
30 minutes
Outcome Measure
Difficult intubation
Outcome Description
'Oxygenation' cannot be achieved using the anatomical conduits of the upper airway
Outcome Time Frame
30 minutes
Outcome Measure
Cannot intubate cannot oxygenate scenario (CICO)
Outcome Description
Cricothyroidotomy, percutaneous tracheostomy, surgical tracheostomy
Outcome Time Frame
30 minutes
Outcome Measure
Emergency front of neck airway (FONA)
Outcome Description
Inhalation of oro-pharyngeal or gastric contents into the larynx and the respiratory tract
Outcome Time Frame
24 hours
Outcome Measure
Aspiration of gastric contents
Outcome Description
Accidental placement of endotracheal tube into the oesophagus
Outcome Time Frame
30 minutes
Outcome Measure
Oesophageal intubation
Outcome Description
Pleural/mediastinal air collection attributable to traumatic airway management
Outcome Time Frame
24 hours
Outcome Measure
Pneumothorax/pneumo-mediastinum
Outcome Description
Any notable change to the patient's dentition attributable to the procedure of endotracheal intubation
Outcome Time Frame
24 hours
Outcome Measure
Dental injury
Outcome Description
Any detectable/clinically relevant airways injury attributable to the endotracheal intubation procedure (e.g.bleeding, tracheal tear/laceration)
Outcome Time Frame
24 hours
Outcome Measure
Airways injury
Outcome Description
Survival status at ICU discharge
Outcome Time Frame
up to 12 weeks
Outcome Measure
ICU mortality
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Daniel Fein
Investigator Email
dafei@montefiore.org
Investigator Phone