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Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion (4hour)

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. Identifier: NCT02388880
Recruitment Status : Terminated (Slower than anticipated enrollment)
First Posted : March 17, 2015
Results First Posted : April 22, 2019
Last Update Posted : April 22, 2019
United States Army Institute of Surgical Research
Information provided by (Responsible Party):
Advanced Circulatory Systems

Brief Summary:
The purpose of the study is to evaluate the physiological response to application of the Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation. The study will evaluate the physiological response to intrathoracic pressure regulation (IPR) therapy in hemodynamically stable patients with compromised cerebral circulation who are on ventilatory support.

Condition or disease Intervention/treatment Phase
Head Injury Intracranial Pathology Compromised Cerebral Perfusion Device: ITPR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physiological Effects of Intrathoracic Pressure Regulation in Patients With Decreased Cerebral Perfusion Due to Brain Injury or Intracranial Pathology (4 Hour Use)
Study Start Date : February 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: ITPR
Use of the ITPR for 240 minutes.
Device: ITPR
Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations.
Other Names:
  • Intrathoracic Pressure Regulator
  • CirQlator

Primary Outcome Measures :
  1. Cerebral Perfusion Pressure (CPP) [ Time Frame: During 240 minutes of device use ]
    Change from baseline CPP compared with the CPP during use of the ITPR.

Secondary Outcome Measures :
  1. Mean Arterial Pressure (MAP) [ Time Frame: baseline to end of ITPR use ]
    Change from baseline MAP compared with the MAP during use of the ITPR.

  2. Intracranial Pressure (ICP) [ Time Frame: baseline to end of ITPR use ]
    Change from baseline ICP compared with the ICP during use of the ITPR.

  3. End-tidal Carbon Dioxide (EtCO2) [ Time Frame: baseline to end of ITPR use ]
    Change from baseline EtCO2 compared with the EtCO2 during use of the ITPR.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ≥18 years of age
  • intubated and mechanically ventilated on a volume controlled mode
  • head injury or other intracranial pathology and compromised cerebral perfusion
  • arterial line in place or alternative with continuous pressure monitoring
  • SpO2 ≥90%
  • mean arterial pressure >55
  • admission to ICU or about to undergo neurosurgery with planned placement of an invasive intracranial pressure monitor
  • inclusion presents no significant delays to planned emergent neurosurgery
  • prior written informed consent

Exclusion Criteria:

  • cardiac or pulmonary injury
  • confirmed pneumothorax or hemothorax
  • 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
  • marked hypertension at time of device use defined as systolic blood pressure >180 mmHg
  • congestive heart failure
  • women with positive serum or urine pregnancy test or breast feeding

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 identifier (NCT number): NCT02388880

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United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Advanced Circulatory Systems
United States Army Institute of Surgical Research
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Responsible Party: Advanced Circulatory Systems Identifier: NCT02388880    
Other Study ID Numbers: ACSI 450-0003
W81XWH-12-C-0181 ( Other Grant/Funding Number: United States Army Institute for Surgical Research )
First Posted: March 17, 2015    Key Record Dates
Results First Posted: April 22, 2019
Last Update Posted: April 22, 2019
Last Verified: March 2019
Keywords provided by Advanced Circulatory Systems:
traumatic brain injury
cerebral perfusion pressure
intrathoracic pressure regulator
Additional relevant MeSH terms:
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Craniocerebral Trauma
Wounds and Injuries
Nervous System Diseases
Trauma, Nervous System