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Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury

Primary Purpose

Head Injury

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
-7 cm H2O ITPR
-12cm H2O ITPR
Sponsored by
Advanced Circulatory Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head Injury focused on measuring traumatic brain injury, TBI, ITPR, intrathoracic pressure regulator, hepatic encephalopathy, pseudotumorcerebri, obstructive hydrocephalus, intracranial hemorrhage

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥15 years of age
  • intubated and mechanically ventilated on a volume controlled mode
  • head injury or other intracranial pathology with ICP of ≥15 mmHg
  • arterial line in place
  • SpO2 ≥95%
  • MAP >60
  • in ICU or about to undergo neurosurgery with planned placement of an ICP monitor
  • inclusion presents no significant delays to planned emergent neurosurgery
  • prior written informed consent

Exclusion Criteria:

  • cardiac or pulmonary injury impacting intrathoracic pressure
  • confirmed pneumothorax or hemothorax
  • PaO2/FiO2 <300
  • serious neck injury resulting in neck swelling with jugular venous compression
  • evidence of ongoing uncontrolled bleeding
  • respiratory disease such as COPD, interstitial lung disease, or other parenchymal or pulmonary vascular disease
  • congestive heart failure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group A

    Group B

    Group C

    Group D

    Arm Description

    tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device

    tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device

    tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device

    tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device

    Outcomes

    Primary Outcome Measures

    Intracranial Pressure (ICP)
    Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.

    Secondary Outcome Measures

    Cerebral Perfusion Pressure (CPP)
    Measurement of the difference between baseline CPP and CPP at 15 minutes
    Lung Compliance
    Change in lung compliance following each ITPR treatment compared to baseline.
    Arterial Blood Gases (PaCO2)
    Arterial blood gases will be collected.

    Full Information

    First Posted
    March 29, 2013
    Last Updated
    February 12, 2015
    Sponsor
    Advanced Circulatory Systems
    Collaborators
    U.S. Army Medical Research and Development Command
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01824589
    Brief Title
    Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
    Official Title
    Effects of Intrathoracic Pressure Regulation Therapy in Patients With Elevated Intracranial Pressure Due to Brain Injury or Intracranial Pathology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    August 2012 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Advanced Circulatory Systems
    Collaborators
    U.S. Army Medical Research and Development Command

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial Perfusion Pressure (ICP) in patients with head injury and elevated ICP, and to determine the optimal ventilation tidal volume (TV).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head Injury
    Keywords
    traumatic brain injury, TBI, ITPR, intrathoracic pressure regulator, hepatic encephalopathy, pseudotumorcerebri, obstructive hydrocephalus, intracranial hemorrhage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    1 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Active Comparator
    Arm Description
    tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Arm Description
    tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device
    Arm Title
    Group C
    Arm Type
    Active Comparator
    Arm Description
    tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device
    Arm Title
    Group D
    Arm Type
    Active Comparator
    Arm Description
    tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device
    Intervention Type
    Device
    Intervention Name(s)
    -7 cm H2O ITPR
    Other Intervention Name(s)
    Intrathoracic Pressure Regulator, CirQlator
    Intervention Description
    Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations.
    Intervention Type
    Device
    Intervention Name(s)
    -12cm H2O ITPR
    Other Intervention Name(s)
    Intrathoracic Pressure Regulatory, CirQlator
    Intervention Description
    Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations.
    Primary Outcome Measure Information:
    Title
    Intracranial Pressure (ICP)
    Description
    Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.
    Time Frame
    15 minutes after device is activated
    Secondary Outcome Measure Information:
    Title
    Cerebral Perfusion Pressure (CPP)
    Description
    Measurement of the difference between baseline CPP and CPP at 15 minutes
    Time Frame
    15 minutes after device activation
    Title
    Lung Compliance
    Description
    Change in lung compliance following each ITPR treatment compared to baseline.
    Time Frame
    baseline and immediately after device removal
    Title
    Arterial Blood Gases (PaCO2)
    Description
    Arterial blood gases will be collected.
    Time Frame
    15 minutes after device activation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ≥15 years of age intubated and mechanically ventilated on a volume controlled mode head injury or other intracranial pathology with ICP of ≥15 mmHg arterial line in place SpO2 ≥95% MAP >60 in ICU or about to undergo neurosurgery with planned placement of an ICP monitor inclusion presents no significant delays to planned emergent neurosurgery prior written informed consent Exclusion Criteria: cardiac or pulmonary injury impacting intrathoracic pressure confirmed pneumothorax or hemothorax PaO2/FiO2 <300 serious neck injury resulting in neck swelling with jugular venous compression evidence of ongoing uncontrolled bleeding respiratory disease such as COPD, interstitial lung disease, or other parenchymal or pulmonary vascular disease congestive heart failure

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury

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