NCT02388880
Terminated
Not Applicable
Physiological Effects of Intrathoracic Pressure Regulation in Patients With Decreased Cerebral Perfusion Due to Brain Injury or Intracranial Pathology (4 Hour Use)
Advanced Circulatory Systems1 site in 1 country3 target enrollmentFebruary 2015
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head Injury
- Sponsor
- Advanced Circulatory Systems
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Cerebral Perfusion Pressure (CPP)
- Status
- Terminated
- Last Updated
- 7 years ago
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.
Investigators
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
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 Outcomes
- Mean Arterial Pressure (MAP)(baseline to end of ITPR use)
- End-tidal Carbon Dioxide (EtCO2)(baseline to end of ITPR use)
- Intracranial Pressure (ICP)(baseline to end of ITPR use)
Study Sites (1)
Loading locations...
Similar Trials
Terminated
Not Applicable
Effect of Intrathoracic Pressure Regulation on Decreased Cerebral PerfusionHead InjuryIntracranial PathologyCompromised Cerebral PerfusionNCT01824576Advanced Circulatory Systems9
Terminated
Phase 4
Effect of Intrathoracic Pressure Regulation on Traumatic Brain InjuryHead InjuryNCT01824589Advanced Circulatory Systems1
Completed
Phase 2
IRB-HSR# 14296 The Use of the Intrathoracic Pressure Regulator (ITPR) to Improve Systemic Blood Pressure in Patient Undergoing CABG SurgeryCoronary Artery DiseaseNCT01205594University of Virginia20
Withdrawn
Not Applicable
Effects of CPAP on Ventricular Function ModificationsHeart Failure, CongestiveNCT00455611Ospedale S. Giovanni Bosco
Completed
Not Applicable
Transpulmonary Driving Pressure and Intra-abdominal Pressure Relationship During Laparoscopic SurgeryAnesthesia, General/MethodsLaparoscopyRespiration, ArtificialPositive-Pressure RespirationEnd-Expiratory Pressure, PositiveVentilator-Induced Lung InjuryNCT03435913Hospital Universitario La Fe30