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

Gestion du Sevrage de la Ventilation mécanique du Patient neurolésé en réanimation et Association Avec le Devenir. Etude Observationnelle Multi-centrique Internationale. Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome. The International Observational ENIO Study.

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.

Study Overview

• Status: Completed
• Conditions: Brain Injuries
• Intervention / Treatment: Other: Patients with brain injury and mechanical ventilation exposed to extubation/tracheostomy

• Study Type: Observational
• Enrollment (Actual): 1750

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • Nantes University Hospital
• India
  • Varanasi, India
    • Varanasi BHU Hospital
• Italy
  • Genova, Italy
    • University of Genes
• Netherlands
  • Amsterdam, Netherlands
    • University of Amsterdam
  • Den Haag, Netherlands
    • Haaglanden (Medical Center)
  • Enschede, Netherlands
    • Enschede (Medisch Spectrum Twente)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing significant brain injury, with a mechanical ventilation duration≥ 24 hours and baseline Gasgow coma score ≤12, undergoing an attempt of extubation and/or tracheostomy

Description

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

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation success	Successful removal of endo-tracheal tube	Extubation failure will be defined as the need to re-intubate the patient within 48hours after removal
Extubation success	Successful removal of endo-tracheal tube	Extubation failure will be defined as the need to re-intubate the patient within 96hours after removal
Extubation success	Successful removal of endo-tracheal tube	Extubation failure will be defined as the need to re-intubate the patient within 168hours (7 days) after removal

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Publications and helpful links

General Publications

• Cinotti R, Pelosi P, Schultz MJ, Aikaterini I, Alvarez P, Badenes R, Mc Credie V, Elbuzidi AS, Elhadi M, Godoy DA, Gurjar M, Haenggi M, Kaye C, Mijangos-Mendez JC, Piagnerelli M, Piracchio R, Reza ST, Stevens RD, Yoshitoyo U, Asehnoune K; ENIO Study Group. Extubation strategies in neuro-intensive care unit patients and associations with outcomes: the ENIO multicentre international observational study. Ann Transl Med. 2020 Apr;8(7):503. doi: 10.21037/atm.2020.03.160.

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2018
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: RC17_0328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All proposals for sub-studies on the main ENIO database are encouraged. Secondary studies must be approved by the steering committee. Study results will be presented and disseminated in a timely manner. Authorship will be proposed by the investigators of the sub-studies and approved by the steering committee. National groups may enter requests for data-access to analyse their national datasets. Owing to the full anonymization of data according to European Union laws and regulations, institutional datasets will not be available.
• IPD Sharing Time Frame: No time limit

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No