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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients with brain injury and mechanical ventilation exposed to extubation/tracheostomy | Other | Extubation and/or tracheostomy if applicable |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Nantes | 44000 | France | |||
| Varanasi BHU Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41528453 | Derived | 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. | |
| 40639639 |
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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.
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No time limit
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D014139 | Tracheostomy |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D010030 | Ostomy |
| D013514 | Surgical Procedures, Operative |
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| 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) |
| Varanasi |
| India |
| University of Genes | Genova | Italy |
| University of Amsterdam | Amsterdam | Netherlands |
| Enschede (Medisch Spectrum Twente) | Enschede | Netherlands |
| Haaglanden (Medical Center) | The Hague | Netherlands |
| 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. |
| 40184992 | Derived | 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. |
| 39961531 | Derived | 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. |
| 38557684 | Derived | 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. |
| 37192445 | Derived | 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. |
| 37081474 | Derived | 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. |
| 32395547 | Derived | 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. |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D013517 |
| Otorhinolaryngologic Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |