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.|
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Head Injury Intracranial Pathology Compromised Cerebral Perfusion||Device: ITPR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Use of the ITPR for 240 minutes.
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.
- 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.
- 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.
- Intracranial Pressure (ICP) [ Time Frame: baseline to end of ITPR use ]Change from baseline ICP compared with the ICP during use of the ITPR.
- 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.
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): NCT02388880
|United States, Texas|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78229|