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Mechanical Ventilation in Brain-injured Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01885507
Acronym
BI-VILI
Enrollment
560
Registered
2013-06-25
Start date
2013-07-31
Completion date
2014-09-30
Last updated
2015-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain-injury, Stroke, Structural Coma, Subarachnoid Haemorrhage, Traumatic Brain Injury

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.

Interventions

OTHERPass recommendations on ventilation factors and extubation

* 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

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mechanical ventilatory free daysDay-90The 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

MeasureTime frameDescription
In-ICU mortality90 days
Duration of mechanical ventilation90 days
ICU free days at day 90day 90The 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
Acute respiratory distress syndrome / acute lung injuryday-90
Hospital acquired pneumoniaday-90
Mortalityday-90
Intracranial pressureday-5
Glasgow outcome scaleday-90
Extubation failureday-90
Ventilatory settingday-5Tidal volume and Positive end expiratory pressure
Blood gazday-5PaO2 (arterial pressure of oxygen) and PaCO2 (arterial pressure of dioxide of carbon)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026