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

Primary Purpose

Head Injury, Intracranial Pathology, Compromised Cerebral Perfusion

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ITPR
Sponsored by
Advanced Circulatory Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head Injury focused on measuring ITPR, CPP, TBI, traumatic brain injury, cerebral perfusion pressure, intrathoracic pressure regulator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ITPR

Arm Description

Use of the ITPR for 240 minutes.

Outcomes

Primary Outcome Measures

Cerebral Perfusion Pressure (CPP)
Change from baseline CPP compared with the CPP during use of the ITPR.

Secondary Outcome Measures

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

Full Information

First Posted
March 10, 2015
Last Updated
March 27, 2019
Sponsor
Advanced Circulatory Systems
Collaborators
United States Army Institute of Surgical Research
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1. Study Identification

Unique Protocol Identification Number
NCT02388880
Brief Title
Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion (4hour)
Official Title
Physiological Effects of Intrathoracic Pressure Regulation in Patients With Decreased Cerebral Perfusion Due to Brain Injury or Intracranial Pathology (4 Hour Use)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Slower than anticipated enrollment
Study Start Date
February 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Circulatory Systems
Collaborators
United States Army Institute of Surgical Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Injury, Intracranial Pathology, Compromised Cerebral Perfusion
Keywords
ITPR, CPP, TBI, traumatic brain injury, cerebral perfusion pressure, intrathoracic pressure regulator

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ITPR
Arm Type
Experimental
Arm Description
Use of the ITPR for 240 minutes.
Intervention Type
Device
Intervention Name(s)
ITPR
Other Intervention Name(s)
Intrathoracic Pressure Regulator, CirQlator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cerebral Perfusion Pressure (CPP)
Description
Change from baseline CPP compared with the CPP during use of the ITPR.
Time Frame
During 240 minutes of device use
Secondary Outcome Measure Information:
Title
Mean Arterial Pressure (MAP)
Description
Change from baseline MAP compared with the MAP during use of the ITPR.
Time Frame
baseline to end of ITPR use
Title
Intracranial Pressure (ICP)
Description
Change from baseline ICP compared with the ICP during use of the ITPR.
Time Frame
baseline to end of ITPR use
Title
End-tidal Carbon Dioxide (EtCO2)
Description
Change from baseline EtCO2 compared with the EtCO2 during use of the ITPR.
Time Frame
baseline to end of ITPR use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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

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