International Observational Study on Airway Management in Critically Ill Patients

Completed

• Conditions: Coma; Hemodynamic Instability; Critical Illness; Respiratory Failure

• Registration Number: NCT03616054
• Lead Sponsor: Azienda Ospedaliera San Gerardo di Monza

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.

Study Timeline

• Study First Submitted: 2018-07-15
• Study First Submitted QC: 2018-08-03
• Study First Posted: 2018-08-06
• Study Start: 2018-10-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-09-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major intubation-related complication	30 minutes	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ASST Monza - University Hospital San Gerardo; 🇮🇹 Monza, Italy