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NCT Number: NCT03400904

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital, Nantes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients with brain injury and mechanical ventilation exposed to extubation/tracheostomy

Other

Extubation and/or tracheostomy if applicable

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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.

Acronym: ENIO

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jan 17, 2018
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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