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TERMINATEDNA

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

Physiological Effects of Intrathoracic Pressure Regulation in Patients With Decreased Cerebral Perfusion Due to Brain Injury or Intracranial Pathology (4 Hour Use)

NCT02388880•Advanced Circulatory Systems

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Key Dates

Start Date

February 1, 2015

Primary Completion Date

November 1, 2016

Completion Date

November 1, 2016

Last Updated

April 22, 2019

Enrollment

ACTUAL participants

Conditions

Head InjuryIntracranial PathologyCompromised Cerebral Perfusion

Interventions

ITPR

DEVICE

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 22, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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