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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03400904
Other study ID # RC17_0328
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 6, 2018
Est. completion date January 1, 2021

Study information

Verified date March 2024
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1750
Est. completion date January 1, 2021
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Nantes University Hospital Nantes
India Varanasi BHU Hospital Varanasi
Italy University of Genes Genova
Netherlands University of Amsterdam Amsterdam
Netherlands Haaglanden (Medical Center) Den Haag
Netherlands Enschede (Medisch Spectrum Twente) Enschede

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Countries where clinical trial is conducted

France,  India,  Italy,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Extubation success Successful removal of endo-tracheal tube Extubation failure will be defined as the need to re-intubate the patient within 48hours after removal
Primary Extubation success Successful removal of endo-tracheal tube Extubation failure will be defined as the need to re-intubate the patient within 96hours after removal
Primary Extubation success Successful removal of endo-tracheal tube Extubation failure will be defined as the need to re-intubate the patient within 168hours (7 days) after removal
Secondary In-ICU VAP Ventilator-acquired pneumonia (VAP) Onset of VAP during ICU stay and after extubation failure, when appropriate (Median 15 days)
Secondary Mechanical ventilation duration Calculation of the duration of Mechanical Ventilation during ICU stay. ICU-stay (Median 15 days)
Secondary Tracheostomy Study the rate and reasons for tracheostomy in patients with brain injury ICU stay (Median 15 days)
Secondary In-ICU mortality Death in the ICU During ICU stay (Median 15 days)
Secondary In-hopsital mortality Death during hospitalization During the first hospital stay following Brain-Injury (Median 25 days)
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