Skip to main content
OpenTrials
Completed

NCT Number: NCT01885507

Mechanical Ventilation in Brain-injured Patients

Protective ventilation (association of a tidal volume < 8 ml/kg with a positive end expiratory pressure) is poorly used in severe brain-injured patients. Moreover, a systematic approach to extubation may decrease the rate of extubation failure and enhance outcomes of brain-injured patients.

We hypothesized that medical education and implementation of an evidence-base care bundle associating protective ventilation and systemic approach to extubation can reduce the duration of mechanical ventilation in brain-injured patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain-injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Structural Coma Subarachnoid Haemorrhage Subarachnoid Hemorrhage Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Angers University Hospital, Angers, France

Loading trial locations.

About this study

A before/after study design will be used. The before period (control phase) will consisted of all consecutive patients with severe brain-injury who were admitted to the participating ICUs.

During the interphase, all physicians, residents, physiotherapists and nurses will receive a formal training for the processes and procedures related to the 2 point bundle: protective ventilation and systematic approach to extubation (according to recommendation for the use of tidal volume < 7 ml/kg and of a positive expiratory pressure = 6 to 8 cmH20 (centimeter of water) and extubation as soon as ventilatory weaning is associated with a glasgow coma scale equal or above 10 and cought).

The after period consisted of all consecutive severe brain-injured patients admitted to the participating ICUs after the formal training.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (traumatic brain-injured, subarachnoid hemorrhage, stroke or other)
  • Brain injury (Glasgow Coma Scale ≤ 12 associated with at least one anomaly related to an acute process on head tomographic tomodensitometry
  • mechanical ventilation for more than 24 hours

Exclusion criteria

  • early decision to withdraw care (taken in the first 24 hours in ICU),
  • death in the first 24 hours

Treatment and study plan

Pass recommendations on ventilation factors and extubation

Other
  • the use of tidal volume < 7 ml/kg and of a positive expiratory pressure = 6 to 8 cmH20 (centimeter of water)
  • extubation as soon as ventilatory weaning is associated with a glasgow coma scale equal or above 10 and cough

Primary outcomes

  1. Mechanical ventilatory free days

    Time frame: Day-90

    The number of ventilator-free days was defined as the number of days from day 1 to day 90 on which a patient breaths spontaneously and is alive

Secondary outcomes

  1. Mortality

    Time frame: day-90

  2. In-ICU mortality

    Time frame: 90 days

  3. Duration of mechanical ventilation

    Time frame: 90 days

  4. ICU free days at day 90

    Time frame: day 90

    The number of ICU free days was defined as the number of days from day 1 to on which a patient is alive and not hospitalized in ICU

  5. Acute respiratory distress syndrome / acute lung injury

    Time frame: day-90

  6. Hospital acquired pneumonia

    Time frame: day-90

  7. Blood gaz

    Time frame: day-5

    PaO2 (arterial pressure of oxygen) and PaCO2 (arterial pressure of dioxide of carbon)

  8. Intracranial pressure

    Time frame: day-5

  9. Glasgow outcome scale

    Time frame: day-90

  10. Extubation failure

    Time frame: day-90

  11. Ventilatory setting

    Time frame: day-5

    Tidal volume and Positive end expiratory pressure

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Duration of Mechanical Ventilation and Mortality Among Brain-injured Patients - a Before-after Evaluation of a Quality Improvement Project

Acronym: BI-VILI

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 25, 2013
Registry last updated
Feb 23, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.