Clinical trial NCT03400904: Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 1750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Extubation success
timeFrame: Extubation failure will be defined as the need to re-intubate the patient within 48hours after removal
measure: Extubation success
timeFrame: Extubation failure will be defined as the need to re-intubate the patient within 96hours after removal
measure: Extubation success
timeFrame: Extubation failure will be defined as the need to re-intubate the patient within 168hours (7 days) after removal
Secondary outcomes:
measure: In-ICU VAP
timeFrame: Onset of VAP during ICU stay and after extubation failure, when appropriate (Median 15 days)
measure: Mechanical ventilation duration
timeFrame: ICU-stay (Median 15 days)
measure: Tracheostomy
timeFrame: ICU stay (Median 15 days)
measure: In-ICU mortality
timeFrame: During ICU stay (Median 15 days)
measure: In-hopsital mortality
timeFrame: During the first hospital stay following Brain-Injury (Median 25 days)
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
city: Varanasi
country: India
facility: Varanasi BHU Hospital
city: Genova
country: Italy
facility: University of Genes
city: Amsterdam
country: Netherlands
facility: University of Amsterdam
city: Den Haag
country: Netherlands
facility: Haaglanden (Medical Center)
city: Enschede
country: Netherlands
facility: Enschede (Medisch Spectrum Twente)
Study officials:
References:
citation: 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.