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

Head Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02388880
• Other study ID #: ACSI 450-0003
• Secondary ID: W81XWH-12-C-0181
• Status: Terminated
• Phase: N/A
• Start date: February 2015
• Est. completion date: November 2016

Study information

• Verified date: March 2019
• Source: Advanced Circulatory Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Compromised Cerebral Perfusion
• Craniocerebral Trauma
• Head Injury
• Intracranial Pathology

Intervention

Device:
• ITPR
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.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Advanced Circulatory Systems	United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral Perfusion Pressure (CPP)	Change from baseline CPP compared with the CPP during use of the ITPR.	During 240 minutes of device use
Secondary	Mean Arterial Pressure (MAP)	Change from baseline MAP compared with the MAP during use of the ITPR.	baseline to end of ITPR use
Secondary	Intracranial Pressure (ICP)	Change from baseline ICP compared with the ICP during use of the ITPR.	baseline to end of ITPR use
Secondary	End-tidal Carbon Dioxide (EtCO2)	Change from baseline EtCO2 compared with the EtCO2 during use of the ITPR.	baseline to end of ITPR use