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Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01955785
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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).

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Device: pressure controlled ventilator Device: Pressure Regulated Volume Controlled Ventilator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury: A Randomised Comparison of Pressure Controlled Ventilation and Pressure Regulated Volume Controlled Ventilation
Study Start Date : September 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PC ventilation
Intervention with pressure controlled ventilator
Device: pressure controlled ventilator
Active Comparator: PRVC ventilation
Intervention with Pressure Regulated Volume Controlled Ventilator
Device: Pressure Regulated Volume Controlled Ventilator



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. PaCO2 [ Time Frame: Two hours ]
    Each subject is studied in several study periods each of two hours duration (max number 6 periods). N=1 design



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01955785


Locations
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Norway
Dept Intensive Care Medicine, St Olavs University Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
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Principal Investigator: Pål Klepstad, MD PhD National Taiwan Normal University
Publications of Results:
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01955785    
Other Study ID Numbers: 2013/1346
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Keywords provided by Norwegian University of Science and Technology:
Traumatic brain injury
Intracranial pressure
Ventilation
Respiratory therapy
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System