Physiological Effects of Intrathoracic Pressure Regulation in Patients With Decreased Cerebral Perfusion Due to Brain Injury or Intracranial Pathology

Advanced Circulatory Systems2 sites in 1 country9 target enrollmentApril 2013

ConditionsHead Injury Intracranial Pathology Compromised Cerebral Perfusion

Overview

Phase: N/A
Intervention: Not specified
Conditions: Head Injury
Sponsor: Advanced Circulatory Systems
Enrollment: 9
Locations: 2
Primary Endpoint: Change From Baseline in Cerebral Perfusion Pressure (CPP)
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

November 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Advanced Circulatory Systems

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change From Baseline in Cerebral Perfusion Pressure (CPP)

Time Frame: During 120 minutes of device use

Change from average baseline CPP compared with the average CPP during use of the ITPR.

Secondary Outcomes

Change From Baseline in Heart Rate (HR)(baseline to 15 minutes following device use)
Change From Baseline in Systolic Blood Pressure (SBP)(baseline to15 minutes following device use)
Change From Baseline in Pulse Pressure (PP)(baseline to 15 minutes following device use)
Change From Baseline in End-tidal Carbon Dioxide (EtCO2)(baseline to 15 minutes following device use)
Change From Baseline in Mean Arterial Pressure (MAP)(baseline to 15 minutes following device use)
Change From Baseline in PaCO2(baseline and 15 minutes after device activation)
Change From Baseline in Diastolic Blood Pressure (DBP)(baseline to 15 minutes following device use)
Change From Baseline in Oxygen Saturation (SpO2)(basseline to 15 minutes following device use)