Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome.

Completed

• Conditions: Brain Injuries

• Registration Number: NCT03400904
• Lead Sponsor: Nantes University Hospital

Brief Summary

Rationale Prolonged mechanical ventilation (MV) is common in patients with severe Brain Injury (BI). Guidelines for the management of extubation are largely lacking for patients with BI, and the role of tracheostomy is highly uncertain. More important, data on practice of management of extubation is yet underreported, as is the use of tracheotomy in this specific subset of critical care patients.

Objective The objective of this prospective observational study is to describe the management of extubation and tracheostomy in intensive care unit (ICU) patients with BI. The aim is to describe the incidence of extubation failure and the rate of tracheostomy.

Study design The "Extubation strategies in Neuro-Intensive care unit patients, and associations with Outcomes (ENIO)" is an observational multicentre international cohort study.

Study population The investigators will include patients undergoing BI, with an initial Glasgow Coma Score ≤ 12 and with a delivered duration of mechanical ventilation (MV) ≥ 24 hours at ICU admission. The inclusion period will last 6 months in total, and each centre is expected to include at least 24 patients during this period. With over 60 ICUs participating worldwide, we expect to include 1500 patients.

Main parameters Parameters to be collected include: general neurological management, ventilatory management, general ICU complications, specific data on extubation and tracheostomy, general in-ICU outcomes and in-hospital mortality.

Nature and extent of the burden and risks associated with participation Because of the observational design of the study using routinely collected data, there is no additional burden for the patient. Collection of data from ICU charts and/or (written or electronic) medical records systems bears no risk to the patients.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-17
• Study Start: 2018-09-06
• Primary Completion: 2020-10-01
• Study Completion: 2021-01-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1750

Inclusion Criteria

• Age ≥ 18 years' old
• Patients admitted in a ICU for a central neurological pathology, listed as follows, with estimated or clinically evaluated Glasgow Coma Score ≤12 before endo-tracheal intubation, with anomaly on brain CT-scan and requiring effective invasive mechanical ventilation ≥ 24 hours are eligible to the study:
• Traumatic Brain Injury
• Aneurysmal Subarachnoid haemorrhage
• Intra-Cranial Haemorrhage
• Ischemic Stroke
• Central Nervous System Infection (Abscess, Empyema, Meningitides, Encephalitis...)
• Brain Tumour
• Patient with an attempt of extubation and/or performance of a tracheostomy

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Exclusion Criteria

• Patients < 18 years' old
• Patients with ongoing pregnancy
• Patients with spine cord injury above T4
• Resuscitated cardiac arrest
• Withdrawal of Life-Sustaining Treatment (WLST) in the first 24 hours

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extubation success	Extubation failure will be defined as the need to re-intubate the patient within 168hours (7 days) after removal	Successful removal of endo-tracheal tube

Secondary Outcome Measures

Name	Time	Method
In-ICU VAP	Onset of VAP during ICU stay and after extubation failure, when appropriate (Median 15 days)	Ventilator-acquired pneumonia (VAP)
Tracheostomy	ICU stay (Median 15 days)	Study the rate and reasons for tracheostomy in patients with brain injury
In-ICU mortality	During ICU stay (Median 15 days)	Death in the ICU
Mechanical ventilation duration	ICU-stay (Median 15 days)	Calculation of the duration of Mechanical Ventilation during ICU stay.
In-hopsital mortality	During the first hospital stay following Brain-Injury (Median 25 days)	Death during hospitalization

Trial Locations

Locations (6)

Varanasi BHU Hospital; 🇮🇳 Varanasi, India

University of Genes; 🇮🇹 Genova, Italy

Nantes University Hospital; 🇫🇷 Nantes, France

Haaglanden (Medical Center); 🇳🇱 Den Haag, Netherlands

University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

Enschede (Medisch Spectrum Twente); 🇳🇱 Enschede, Netherlands