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Clinical Trials/NCT01955785
NCT01955785
Completed
Not Applicable

Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury: A Randomised Comparison of Pressure Controlled Ventilation and Pressure Regulated Volume Controlled Ventilation

Norwegian University of Science and Technology1 site in 1 country11 target enrollmentSeptember 2013
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ConditionsTraumatic Brain Injury

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Norwegian University of Science and Technology
Enrollment
11
Locations
1
Primary Endpoint
ICP
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Intracranial pressure (ICP) in patients with traumatic brain injury (TBI) is influenced by several factors of which one is arterial CO2 tension. Patient with TBI are often sedated and mechanically ventilated in order to secure a stable PaCO2. This study compares two ventilation modus; Pressure Controlled Ventilation (PC) and Pressure Regulated Volume Controlled ventilation (PRVC) in order to observe which of the two ventilation strategies results in a more stable ICP and arterial CO2 pressure (PaCO2).

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
September 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Informed consent obtained from the patients next-of-kin.
  • •moderate or severe TBI according to Head Injury Severity Scale (Glasgow Coma Scale (GCS) score 3-13).
  • •treated at the neurosurgical ICU or the main ICU at St Olav University Hospital.
  • •intubated and receiving controlled mechanical ventilation.
  • •continuous measurement of ICP with either an intraventricular or an intraparenchymal pressure monitor device.
  • •sedation to a level of sedation corresponding to MAAS (Motor Activity Assessment Score) 0 or 1 with continuous intravenous infusions of midazolam/propofol and morphine/fentanyl/remifentanil14.

Exclusion Criteria

  • •Pregnancy
  • •ICP above 25 mmHg
  • •ongoing cerebral anti edema therapy corresponding to Step III at St Olav University Hospital therapy guideline
  • •continuous external drainage of cerebrospinal fluid (CSF)
  • •Clinical pulmonary condition prohibiting changes in respiratory therapy

Outcomes

Primary Outcomes

ICP

Time Frame: Two hours

Each study period is two hours. All patients receive several study periods (max number 6) in a N=1 design

Secondary Outcomes

  • PaCO2(Two hours)

Study Sites (1)

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