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Mechanical Ventilation in Brain-injured Patients (BI-VILI)

N

Nantes University Hospital (NUH)

Status

Completed

Conditions

Traumatic Brain Injury
Stroke
Brain-injury
Structural Coma
Subarachnoid Haemorrhage

Treatments

Other: Pass recommendations on ventilation factors and extubation

Study type

Observational

Funder types

Other

Identifiers

NCT01885507
RC13_0127

Details and patient eligibility

About

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.

Full description

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.

Enrollment

560 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

560 participants in 2 patient groups

Control phase (before)
Description:
Process of care and outcomes before the educational program
Training phase (after)
Description:
Process of care and outcomes after the educational program which recommends: * 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
Treatment:
Other: Pass recommendations on ventilation factors and extubation

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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