Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome. (ENIO)
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|ClinicalTrials.gov Identifier: NCT03400904|
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : March 11, 2022
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.
|Condition or disease||Intervention/treatment|
|Brain Injuries||Other: Patients with brain injury and mechanical ventilation exposed to extubation/tracheostomy|
|Study Type :||Observational|
|Actual Enrollment :||1750 participants|
|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.|
|Actual Study Start Date :||September 6, 2018|
|Actual Primary Completion Date :||October 1, 2020|
|Actual Study Completion Date :||January 1, 2021|
- Other: Patients with brain injury and mechanical ventilation exposed to extubation/tracheostomy
Extubation and/or tracheostomy if applicable
- Extubation success [ Time Frame: Extubation failure will be defined as the need to re-intubate the patient within 48hours after removal ]Successful removal of endo-tracheal tube
- Extubation success [ Time Frame: Extubation failure will be defined as the need to re-intubate the patient within 96hours after removal ]Successful removal of endo-tracheal tube
- Extubation success [ Time Frame: 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
- In-ICU VAP [ Time Frame: Onset of VAP during ICU stay and after extubation failure, when appropriate (Median 15 days) ]Ventilator-acquired pneumonia (VAP)
- Mechanical ventilation duration [ Time Frame: ICU-stay (Median 15 days) ]Calculation of the duration of Mechanical Ventilation during ICU stay.
- Tracheostomy [ Time Frame: ICU stay (Median 15 days) ]Study the rate and reasons for tracheostomy in patients with brain injury
- In-ICU mortality [ Time Frame: During ICU stay (Median 15 days) ]Death in the ICU
- In-hopsital mortality [ Time Frame: During the first hospital stay following Brain-Injury (Median 25 days) ]Death during hospitalization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400904
|Nantes University Hospital|
|Nantes, France, 44000|
|Varanasi BHU Hospital|
|University of Genes|
|University of Amsterdam|
|Haaglanden (Medical Center)|
|Den Haag, Netherlands|
|Enschede (Medisch Spectrum Twente)|