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Brain InjuriesENIONCT03400904

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

An observational study of Brain Injuries, run by Nantes University Hospital at 6 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Injuries
What is being tested?
Patients with brain injury and mechanical ventilation exposed to extubation/tracheostomy
How many people
1,750 participants
Where
6 sitesin 4 countries
Study dates
6 Sep 2018to 1 Jan 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 9Show fewer
  • Central Nervous System Infection (Abscess, Empyema, Meningitides, Encephalitis…)
  • Brain Tumour
  • Patient with an attempt of extubation and/or performance of a tracheostomy

Who cannot join

  • 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

Trial locations and contacts

6 sites in 4 countries.

6 sites in 4 countries

Netherlands3 sites

  • University of Amsterdam

    Amsterdam

  • Enschede (Medisch Spectrum Twente)

    Enschede

  • Haaglanden (Medical Center)

    The Hague

Other trials in Netherlands

France1 site

  • Nantes University Hospital

    Nantes, 44000

Other trials in France

India1 site

  • Varanasi BHU Hospital

    Varanasi

Other trials in India

Italy1 site

  • University of Genes

    Genova

Other trials in Italy

About this study

Official title: 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.

Read more

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.

Conditions
Brain Injuries
Being tested
Patients with brain injury and mechanical ventilation exposed to extubation/tracheostomy
Medical subject headings
Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patients with brain injury and mechanical ventilation exposed to extubation/tracheostomyOther

    Extubation and/or tracheostomy if applicable

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Extubation success

    Successful removal of endo-tracheal tube

    Measured: Extubation failure will be defined as the need to re-intubate the patient within 48hours after removal

  2. Extubation success

    Successful removal of endo-tracheal tube

    Measured: Extubation failure will be defined as the need to re-intubate the patient within 96hours after removal

  3. Extubation success

    Successful removal of endo-tracheal tube

    Measured: Extubation failure will be defined as the need to re-intubate the patient within 168hours (7 days) after removal

Secondary outcomes (5)

  1. In-ICU VAP

    Ventilator-acquired pneumonia (VAP)

    Measured: Onset of VAP during ICU stay and after extubation failure, when appropriate (Median 15 days)

  2. Mechanical ventilation duration

    Calculation of the duration of Mechanical Ventilation during ICU stay.

    Measured: ICU-stay (Median 15 days)

  3. Tracheostomy

    Study the rate and reasons for tracheostomy in patients with brain injury

    Measured: ICU stay (Median 15 days)

  4. In-ICU mortality

    Death in the ICU

    Measured: During ICU stay (Median 15 days)

  5. In-hopsital mortality

    Death during hospitalization

    Measured: During the first hospital stay following Brain-Injury (Median 25 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2018
  2. Study start6 Sep 2018
  3. Primary completion1 Oct 2020
  4. Study completion1 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,750 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03400904
Sponsor's protocol ID
RC17_0328
Acronym
ENIO
Status last verified
Mar 2024
First submitted
2 Jan 2018
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Battaglini D, Taran S, Gualdi F, Cinotti R, Asehnoune K, Loggini A, Montagnani L, Rocco PRM, Schultz MJ, Patroniti NA, Robba C; ENIO Collaborators. Spontaneous breathing trials as predictors of extubation outcomes in neurocritical care: insights from the ENIO study. Intensive Care Med. 2026 Feb;52(2):252-262. doi: 10.1007/s00134-025-08258-5. Epub 2026 Jan 13.

    PubMed 41528453

  • Daza JF, Hamad DM, Urner M, Liu K, Wahlster S, Robba C, Stevens RD, McCredie VA, Cinotti R, Taran S; ENIO Study Group; PROtective VENTilation Network; European Society of Intensive Care Medicine; Colegio Mexicano de Medicina Critica; AtlanRea Group; Societe Francaise d'Anesthesie-Reanimation-SFAR Research Network. Low-Tidal-Volume Ventilation and Mortality in Patients With Acute Brain Injury: A Secondary Analysis of an International Observational Study. Chest. 2025 Nov;168(5):1141-1151. doi: 10.1016/j.chest.2025.06.042. Epub 2025 Jul 8.

    PubMed 40639639

  • van Vliet R, van Meenen DMP, Robba C, Cinotti R, Asehnoune K, Stevens RD, Battaglini D, Taran S, van der Jagt M, Taccone FS, Paulus F, Schultz MJ; ENIO investigators. Association of age with extubation failure in neurocritical intensive care unit patients--Insight from an international prospective study named ENIO. J Crit Care. 2025 Aug;88:155067. doi: 10.1016/j.jcrc.2025.155067. Epub 2025 Apr 3.

    PubMed 40184992

  • Serafini SC, Cinotti R, Asehnoune K, Battaglini D, Robba C, Neto AS, Pisani L, Mazzinari G, Tschernko EM, Schultz MJ; PRoVENT, the PRoVENT-iMiC and ENIO, investigators. Potentially modifiable ventilation factors associated with outcome in neurocritical care vs. non-neurocritical care patients: Rational and protocol for a patient-level analysis of PRoVENT, PRoVENT-iMiC and ENIO (PRIME). Rev Esp Anestesiol Reanim (Engl Ed). 2025 May;72(5):501690. doi: 10.1016/j.redare.2025.501690. Epub 2025 Feb 15.

    PubMed 39961531

  • Taran S, Perrot B, Angriman F, Cinotti R; Extubation strategies in Neuro-Intensive care unit patients and associations with Outcomes (ENIO) Study Group; PROtective VENTilation network; European Society of Intensive Care Medicine; Colegio Mexicano de Medicina Critica; Atlanrea group, and the Societe Francaise d'Anesthesie et de Reanimation (SFAR) research network; Extubation strategies in Neuro-Intensive care unit patients and associations with Outcomes (ENIO) Study Group and PROtective VENTilation network and the European Society of Intensive Care Medicine and the Colegio Mexicano de Medicina Critica and the Atlanrea group, and the Societe Francaise d'Anesthesie et de Reanimation (SFAR) research network. Evaluating the Sum of Eye and Motor Components of the Glasgow Coma Score As a Predictor of Extubation Failure in Patients With Acute Brain Injury. Crit Care Med. 2024 Aug 1;52(8):1258-1263. doi: 10.1097/CCM.0000000000006283. Epub 2024 Apr 1.

    PubMed 38557684

  • Taran S, Diaz-Cruz C, Perrot B, Alvarez P, Godoy DA, Gurjar M, Haenggi M, Mijangos JC, Pelosi P, Robba C, Schultz MJ, Ueno Y, Asehnoune K, Cho SM, Yarnell CJ, Cinotti R, Stevens RD. Association of Noninvasive Respiratory Support with Extubation Outcomes in Brain-injured Patients Receiving Mechanical Ventilation: A Secondary Analysis of the ENIO Prospective Observational Study. Am J Respir Crit Care Med. 2023 Aug 1;208(3):270-279. doi: 10.1164/rccm.202212-2249OC.

    PubMed 37192445

  • Wahlster S, Sharma M, Taran S, Town JA, Stevens RD, Cinotti R, Asehoune K, Pelosi P, Robba C; ENIO Study Group Collaborators. Utilization of mechanical power and associations with clinical outcomes in brain injured patients: a secondary analysis of the extubation strategies in neuro-intensive care unit patients and associations with outcome (ENIO) trial. Crit Care. 2023 Apr 20;27(1):156. doi: 10.1186/s13054-023-04410-z.

    PubMed 37081474

  • 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.

    PubMed 32395547

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Injuries, run by Nantes University Hospital at 6 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands, France, India, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extubation success (time frame: Extubation failure will be defined as the need to re-intubate the patient within 48hours after removal). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03400904, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.

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