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

Not Applicable

Terminated

• Conditions: Intracranial Pathology; Head Injury; Compromised Cerebral Perfusion
• Interventions: Device: ITPR

• Registration Number: NCT02388880
• Lead Sponsor: Advanced Circulatory Systems

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-17
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2019-03
• Results First Submitted: 2019-03-27
• Results First Submitted QC: 2019-03-27
• Last Update Submitted: 2019-03-27
• Results First Posted: 2019-04-22
• Last Update Posted: 2019-04-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ITPR	ITPR	Use of the ITPR for 240 minutes.

Primary Outcome Measures

Name	Time	Method
Cerebral Perfusion Pressure (CPP)	During 240 minutes of device use	Change from baseline CPP compared with the CPP during use of the ITPR.

Secondary Outcome Measures

Name	Time	Method
Mean Arterial Pressure (MAP)	baseline to end of ITPR use	Change from baseline MAP compared with the MAP during use of the ITPR.
End-tidal Carbon Dioxide (EtCO2)	baseline to end of ITPR use	Change from baseline EtCO2 compared with the EtCO2 during use of the ITPR.
Intracranial Pressure (ICP)	baseline to end of ITPR use	Change from baseline ICP compared with the ICP during use of the ITPR.

Trial Locations

Locations (1)

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States