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

Brain Injuries Clinical Trial

— ENIO  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400904
• Other study ID #: RC17_0328
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Brain Injuries

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)