Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion

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

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.

Study Overview

• Status: Terminated
• Conditions: Head Injury; Intracranial Pathology; Compromised Cerebral Perfusion
• Intervention / Treatment: Device: ITPR

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States
      • Denver
  • Maryland
    • Baltimore, Maryland, United States
      • Baltimore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ITPR; Use of the ITPR for 120 minutes.	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.; Other Names: Intrathoracic Pressure Regulator; CirQlator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Advanced Circulatory Systems
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: March 29, 2013
• First Submitted That Met QC Criteria: April 2, 2013
• First Posted (Estimate): April 5, 2013

Study Record Updates

• Last Update Posted (Actual): September 27, 2017
• Last Update Submitted That Met QC Criteria: August 30, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: TBI; traumatic brain injury; CPP; cerebral perfusion pressure; ITPR; intrathoracic pressure regulator
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Craniocerebral Trauma
• Other Study ID Numbers: ACSI 5R44NS054372; 5R44NS054372 (U.S. NIH Grant/Contract)