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

• ClinicalTrials.gov Identifier: NCT03400904
• Recruitment Status: Completed
• First Posted: January 17, 2018
• Last Update Posted: March 11, 2022
• Sponsor: Nantes University Hospital
• Information provided by (Responsible Party): Karim ASEHNOUNE, Nantes University Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Brain Injuries	Other: Patients with brain injury and mechanical ventilation exposed to extubation/tracheostomy

Study Design

• Study Type: Observational
• Actual Enrollment: 1750 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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

Groups and Cohorts

Intervention Details:

• Other: Patients with brain injury and mechanical ventilation exposed to extubation/tracheostomy
  Extubation and/or tracheostomy if applicable

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Criteria

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

Contacts and Locations

Locations

France

Nantes University Hospital

Nantes, France, 44000

India

Varanasi BHU Hospital

Varanasi, India

Italy

University of Genes

Genova, Italy

Netherlands

University of Amsterdam

Amsterdam, Netherlands

Haaglanden (Medical Center)

Den Haag, Netherlands

Enschede (Medisch Spectrum Twente)

Enschede, Netherlands

Sponsors and Collaborators

Nantes University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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-Méndez 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.

• Responsible Party: Karim ASEHNOUNE, Chief Investigator, Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT03400904
• Other Study ID Numbers: RC17_0328
• First Posted: January 17, 2018
• Last Update Posted: March 11, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Time Frame: No time limit

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries