Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01824576
• Other study ID #: ACSI 5R44NS054372
• Secondary ID: 5R44NS054372
• Status: Terminated
• Phase: N/A
• First received: March 29, 2013
• Last updated: August 30, 2017
• Start date: April 2013
• Est. completion date: November 2016

Study information

• Verified date: August 2017
• 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: 9
• 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	Baltimore	Baltimore	Maryland
United States	Denver	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Advanced Circulatory Systems	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Cerebral Perfusion Pressure (CPP)	Change from average baseline CPP compared with the average CPP during use of the ITPR.	During 120 minutes of device use
Secondary	Change From Baseline in Systolic Blood Pressure (SBP)	Measure change in systolic blood pressure average during baseline and 15 minutes following removal of the ITPR	baseline to15 minutes following device use
Secondary	Change From Baseline in PaCO2	PaCO2 will be collected during baseline and 15 minutes after device activation and change will be evaluated.	baseline and 15 minutes after device activation
Secondary	Change From Baseline in Diastolic Blood Pressure (DBP)	Measure change in diastolic blood pressure average during baseline and 15 minutes following removal of the ITPR	baseline to 15 minutes following device use
Secondary	Change From Baseline in Mean Arterial Pressure (MAP)	Measure change in mean arterial pressure average during baseline and 15 minutes following removal of the ITPR	baseline to 15 minutes following device use
Secondary	Change From Baseline in Heart Rate (HR)	Measure change in heart rate average during baseline and 15 minutes following removal of the ITPR	baseline to 15 minutes following device use
Secondary	Change From Baseline in Pulse Pressure (PP)	Measure change in pulse pressure average during baseline and 15 minutes following removal of the ITPR	baseline to 15 minutes following device use
Secondary	Change From Baseline in End-tidal Carbon Dioxide (EtCO2)	Measure change in EtCO2 average during baseline and 15 minutes following removal of the ITPR	baseline to 15 minutes following device use
Secondary	Change From Baseline in Oxygen Saturation (SpO2)	Measure change in SpO2 average during baseline and 15 minutes following removal of the ITPR	basseline to 15 minutes following device use