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Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT01824589
Recruitment Status : Terminated
First Posted : April 5, 2013
Results First Posted : February 16, 2015
Last Update Posted : February 16, 2015
Sponsor:
Collaborator:
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Advanced Circulatory Systems

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).

Condition or disease Intervention/treatment Phase
Head Injury Device: -7 cm H2O ITPR Device: -12cm H2O ITPR Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Intrathoracic Pressure Regulation Therapy in Patients With Elevated Intracranial Pressure Due to Brain Injury or Intracranial Pathology
Study Start Date : August 2012
Actual Primary Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device
Device: -7 cm H2O ITPR
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.
Other Name: Intrathoracic Pressure Regulator, CirQlator

Active Comparator: Group B
tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device
Device: -7 cm H2O ITPR
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.
Other Name: Intrathoracic Pressure Regulator, CirQlator

Active Comparator: Group C
tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device
Device: -12cm H2O ITPR
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.
Other Name: Intrathoracic Pressure Regulatory, CirQlator

Active Comparator: Group D
tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device
Device: -12cm H2O ITPR
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.
Other Name: Intrathoracic Pressure Regulatory, CirQlator




Primary Outcome Measures :
  1. Intracranial Pressure (ICP) [ Time Frame: 15 minutes after device is activated ]
    Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.


Secondary Outcome Measures :
  1. Cerebral Perfusion Pressure (CPP) [ Time Frame: 15 minutes after device activation ]
    Measurement of the difference between baseline CPP and CPP at 15 minutes

  2. Lung Compliance [ Time Frame: baseline and immediately after device removal ]
    Change in lung compliance following each ITPR treatment compared to baseline.

  3. Arterial Blood Gases (PaCO2) [ Time Frame: 15 minutes after device activation ]
    Arterial blood gases will be collected.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Advanced Circulatory Systems
ClinicalTrials.gov Identifier: NCT01824589     History of Changes
Other Study ID Numbers: ACSI W81XWH-11-1-0542
W81XWH-11-1-0542 ( Other Grant/Funding Number: Department of Defense )
First Posted: April 5, 2013    Key Record Dates
Results First Posted: February 16, 2015
Last Update Posted: February 16, 2015
Last Verified: February 2015

Keywords provided by Advanced Circulatory Systems:
traumatic brain injury
TBI
ITPR
intrathoracic pressure regulator
hepatic encephalopathy
pseudotumorcerebri
obstructive hydrocephalus
intracranial hemorrhage

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Craniocerebral Trauma
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System