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Clinical Trials/NCT01885507
NCT01885507
Completed
N/A

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

Nantes University Hospital21 sites in 1 country560 target enrollmentJuly 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Brain-injury
Sponsor
Nantes University Hospital
Enrollment
560
Locations
21
Primary Endpoint
Mechanical ventilatory free days
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
September 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Acute respiratory distress syndrome / acute lung injury(day-90)
  • Mortality(day-90)
  • ICU free days at day 90(day 90)
  • Intracranial pressure(day-5)
  • Ventilatory setting(day-5)
  • In-ICU mortality(90 days)
  • Extubation failure(day-90)
  • Duration of mechanical ventilation(90 days)
  • Hospital acquired pneumonia(day-90)
  • Blood gaz(day-5)
  • Glasgow outcome scale(day-90)

Study Sites (21)

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