Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion
Primary Purpose
Head Injury, Intracranial Pathology, Compromised Cerebral Perfusion
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ITPR
Sponsored by
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
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
- Denver
- Baltimore
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ITPR
Arm Description
Use of the ITPR for 120 minutes.
Outcomes
Primary Outcome Measures
Change From Baseline in Cerebral Perfusion Pressure (CPP)
Change from average baseline CPP compared with the average CPP during use of the ITPR.
Secondary Outcome Measures
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
Change From Baseline in PaCO2
PaCO2 will be collected during baseline and 15 minutes after device activation and change will be evaluated.
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
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
Change From Baseline in Heart Rate (HR)
Measure change in heart rate average during baseline and 15 minutes following removal of the ITPR
Change From Baseline in Pulse Pressure (PP)
Measure change in pulse pressure average during baseline and 15 minutes following removal of the ITPR
Change From Baseline in End-tidal Carbon Dioxide (EtCO2)
Measure change in EtCO2 average during baseline and 15 minutes following removal of the ITPR
Change From Baseline in Oxygen Saturation (SpO2)
Measure change in SpO2 average during baseline and 15 minutes following removal of the ITPR
Full Information
NCT ID
NCT01824576
First Posted
March 29, 2013
Last Updated
August 30, 2017
Sponsor
Advanced Circulatory Systems
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT01824576
Brief Title
Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion
Official Title
Physiological Effects of Intrathoracic Pressure Regulation in Patients With Decreased Cerebral Perfusion Due to Brain Injury or Intracranial Pathology
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Enrollment was slower than anticipated.
Study Start Date
April 2013 (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
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Data Monitoring Committee
No
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
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ITPR
Arm Type
Experimental
Arm Description
Use of the ITPR for 120 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
Change From Baseline in Cerebral Perfusion Pressure (CPP)
Description
Change from average baseline CPP compared with the average CPP during use of the ITPR.
Time Frame
During 120 minutes of device use
Secondary Outcome Measure Information:
Title
Change From Baseline in Systolic Blood Pressure (SBP)
Description
Measure change in systolic blood pressure average during baseline and 15 minutes following removal of the ITPR
Time Frame
baseline to15 minutes following device use
Title
Change From Baseline in PaCO2
Description
PaCO2 will be collected during baseline and 15 minutes after device activation and change will be evaluated.
Time Frame
baseline and 15 minutes after device activation
Title
Change From Baseline in Diastolic Blood Pressure (DBP)
Description
Measure change in diastolic blood pressure average during baseline and 15 minutes following removal of the ITPR
Time Frame
baseline to 15 minutes following device use
Title
Change From Baseline in Mean Arterial Pressure (MAP)
Description
Measure change in mean arterial pressure average during baseline and 15 minutes following removal of the ITPR
Time Frame
baseline to 15 minutes following device use
Title
Change From Baseline in Heart Rate (HR)
Description
Measure change in heart rate average during baseline and 15 minutes following removal of the ITPR
Time Frame
baseline to 15 minutes following device use
Title
Change From Baseline in Pulse Pressure (PP)
Description
Measure change in pulse pressure average during baseline and 15 minutes following removal of the ITPR
Time Frame
baseline to 15 minutes following device use
Title
Change From Baseline in End-tidal Carbon Dioxide (EtCO2)
Description
Measure change in EtCO2 average during baseline and 15 minutes following removal of the ITPR
Time Frame
baseline to 15 minutes following device use
Title
Change From Baseline in Oxygen Saturation (SpO2)
Description
Measure change in SpO2 average during baseline and 15 minutes following removal of the ITPR
Time Frame
basseline to 15 minutes following device 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
Denver
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Baltimore
City
Baltimore
State/Province
Maryland
Country
United States
12. IPD Sharing Statement
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Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion
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