- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02388880
Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion (4hour)
March 27, 2019 updated by: Advanced Circulatory Systems
Physiological Effects of Intrathoracic Pressure Regulation in Patients With Decreased Cerebral Perfusion Due to Brain Injury or Intracranial Pathology (4 Hour Use)
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- University of Texas Health Science Center at San Antonio
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ITPR
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
During 240 minutes of device use
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline to end of ITPR use
|
Intracranial Pressure (ICP)
Time Frame: baseline to end of ITPR use
|
Change from baseline ICP compared with the ICP during use of the ITPR.
|
baseline to end of ITPR use
|
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.
|
baseline to end of ITPR use
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
March 10, 2015
First Submitted That Met QC Criteria
March 10, 2015
First Posted (Estimate)
March 17, 2015
Study Record Updates
Last Update Posted (Actual)
April 22, 2019
Last Update Submitted That Met QC Criteria
March 27, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACSI 450-0003
- W81XWH-12-C-0181 (Other Grant/Funding Number: United States Army Institute for Surgical Research)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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