CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,750 enrolled
Drug / intervention
Patients with brain injury and mechanical ventilation exposed to extubation/tracheostomyother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03400904
NCT03400904N/ACompleted

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.

Nantes University Hospital·observational·Posted Jan 17, 2018·Updated Apr 2, 2024

In Brief

An observational study evaluating Patients with brain injury and mechanical ventilation exposed to extubation/tracheostomy for Brain Injuries. Completed, enrolled 1,750 participants across 6 sites in 4 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Injuries
CountriesFrance, India, Italy, Netherlands
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 17, 2018
Enrollment StartSep 6, 2018
Primary CompletionOct 1, 2020
Study CompletionJan 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.5 years ago

Interventions

Patients with brain injury and mechanical ventilation exposed to extubation/tracheostomyother

Extubation and/or tracheostomy if applicable