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 Type
OBSERVATIONAL
Enrollment
1,750
Extubation and/or tracheostomy if applicable
Nantes University Hospital
Nantes, France
Varanasi BHU Hospital
Varanasi, India
University of Genes
Genova, Italy
University of Amsterdam
Amsterdam, Netherlands
Enschede (Medisch Spectrum Twente)
Enschede, Netherlands
Haaglanden (Medical Center)
The Hague, Netherlands
Extubation success
Successful removal of endo-tracheal tube
Time frame: 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
Time frame: 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
Time frame: Extubation failure will be defined as the need to re-intubate the patient within 168hours (7 days) after removal
In-ICU VAP
Ventilator-acquired pneumonia (VAP)
Time frame: 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.
Time frame: ICU-stay (Median 15 days)
Tracheostomy
Study the rate and reasons for tracheostomy in patients with brain injury
Time frame: ICU stay (Median 15 days)
In-ICU mortality
Death in the ICU
Time frame: During ICU stay (Median 15 days)
In-hopsital mortality
Death during hospitalization
Time frame: During the first hospital stay following Brain-Injury (Median 25 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.