International Observational Study on Airway Management in Critically Ill Patients

Critical Illness Clinical Trial

— INTUBE  

Official title:

INternational Observational Study To Understand the Impact and BEst Practices of Airway Management in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03616054
• Other study ID #: INTUBE
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: February 2020
• Source: Azienda Ospedaliera San Gerardo di Monza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3600
• Est. completion date: September 30, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coma
• Critical Illness
• Hemodynamic Instability
• Respiratory Failure
• Respiratory Insufficiency

Locations

Country	Name	City	State
Italy	ASST Monza - University Hospital San Gerardo	Monza

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Gerardo di Monza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major intubation-related complication	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.	30 minutes
Secondary	Cardiac arrhythmia	New onset of any supraventricular or ventricular arrhythmia	30 minutes
Secondary	Difficult intubation	> 2 laryngoscopic attempts	30 minutes
Secondary	Cannot intubate cannot oxygenate scenario (CICO)	'Oxygenation' cannot be achieved using the anatomical conduits of the upper airway	30 minutes
Secondary	Emergency front of neck airway (FONA)	Cricothyroidotomy, percutaneous tracheostomy, surgical tracheostomy	30 minutes
Secondary	Aspiration of gastric contents	Inhalation of oro-pharyngeal or gastric contents into the larynx and the respiratory tract	24 hours
Secondary	Oesophageal intubation	Accidental placement of endotracheal tube into the oesophagus	30 minutes
Secondary	Pneumothorax/pneumo-mediastinum	Pleural/mediastinal air collection attributable to traumatic airway management	24 hours
Secondary	Dental injury	Any notable change to the patient's dentition attributable to the procedure of endotracheal intubation	24 hours
Secondary	Airways injury	Any detectable/clinically relevant airways injury attributable to the endotracheal intubation procedure (e.g.bleeding, tracheal tear/laceration)	24 hours
Secondary	ICU mortality	Survival status at ICU discharge	up to 12 weeks

External Links

•   Study website