Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
Primary Purpose
Head Injury
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
-7 cm H2O ITPR
-12cm H2O ITPR
Sponsored by
About this trial
This is an interventional treatment trial for Head Injury focused on measuring traumatic brain injury, TBI, ITPR, intrathoracic pressure regulator, hepatic encephalopathy, pseudotumorcerebri, obstructive hydrocephalus, intracranial hemorrhage
Eligibility Criteria
Inclusion Criteria:
- ≥15 years of age
- intubated and mechanically ventilated on a volume controlled mode
- head injury or other intracranial pathology with ICP of ≥15 mmHg
- arterial line in place
- SpO2 ≥95%
- MAP >60
- in ICU or about to undergo neurosurgery with planned placement of an ICP monitor
- inclusion presents no significant delays to planned emergent neurosurgery
- prior written informed consent
Exclusion Criteria:
- cardiac or pulmonary injury impacting intrathoracic pressure
- confirmed pneumothorax or hemothorax
- PaO2/FiO2 <300
- 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
- congestive heart failure
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Group D
Arm Description
tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device
tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device
tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device
tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device
Outcomes
Primary Outcome Measures
Intracranial Pressure (ICP)
Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.
Secondary Outcome Measures
Cerebral Perfusion Pressure (CPP)
Measurement of the difference between baseline CPP and CPP at 15 minutes
Lung Compliance
Change in lung compliance following each ITPR treatment compared to baseline.
Arterial Blood Gases (PaCO2)
Arterial blood gases will be collected.
Full Information
NCT ID
NCT01824589
First Posted
March 29, 2013
Last Updated
February 12, 2015
Sponsor
Advanced Circulatory Systems
Collaborators
U.S. Army Medical Research and Development Command
1. Study Identification
Unique Protocol Identification Number
NCT01824589
Brief Title
Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
Official Title
Effects of Intrathoracic Pressure Regulation Therapy in Patients With Elevated Intracranial Pressure Due to Brain Injury or Intracranial Pathology
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Circulatory Systems
Collaborators
U.S. Army Medical Research and Development Command
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial Perfusion Pressure (ICP) in patients with head injury and elevated ICP, and to determine the optimal ventilation tidal volume (TV).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Injury
Keywords
traumatic brain injury, TBI, ITPR, intrathoracic pressure regulator, hepatic encephalopathy, pseudotumorcerebri, obstructive hydrocephalus, intracranial hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device
Intervention Type
Device
Intervention Name(s)
-7 cm H2O ITPR
Other Intervention Name(s)
Intrathoracic Pressure Regulator, CirQlator
Intervention Description
Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations.
Intervention Type
Device
Intervention Name(s)
-12cm H2O ITPR
Other Intervention Name(s)
Intrathoracic Pressure Regulatory, CirQlator
Intervention Description
Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations.
Primary Outcome Measure Information:
Title
Intracranial Pressure (ICP)
Description
Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.
Time Frame
15 minutes after device is activated
Secondary Outcome Measure Information:
Title
Cerebral Perfusion Pressure (CPP)
Description
Measurement of the difference between baseline CPP and CPP at 15 minutes
Time Frame
15 minutes after device activation
Title
Lung Compliance
Description
Change in lung compliance following each ITPR treatment compared to baseline.
Time Frame
baseline and immediately after device removal
Title
Arterial Blood Gases (PaCO2)
Description
Arterial blood gases will be collected.
Time Frame
15 minutes after device activation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥15 years of age
intubated and mechanically ventilated on a volume controlled mode
head injury or other intracranial pathology with ICP of ≥15 mmHg
arterial line in place
SpO2 ≥95%
MAP >60
in ICU or about to undergo neurosurgery with planned placement of an ICP monitor
inclusion presents no significant delays to planned emergent neurosurgery
prior written informed consent
Exclusion Criteria:
cardiac or pulmonary injury impacting intrathoracic pressure
confirmed pneumothorax or hemothorax
PaO2/FiO2 <300
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
congestive heart failure
12. IPD Sharing Statement
Learn more about this trial
Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
We'll reach out to this number within 24 hrs