Compromised Cerebral Perfusion, Head Injury, Intracranial Pathology
Conditions
Keywords
ITPR, CPP, TBI, traumatic brain injury, cerebral perfusion pressure, intrathoracic pressure regulator
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.
Interventions
DEVICEITPR
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.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Advanced Circulatory Systems
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Cerebral Perfusion Pressure (CPP) | During 120 minutes of device use | Change from average baseline CPP compared with the average CPP during use of the ITPR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in PaCO2 | baseline and 15 minutes after device activation | 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) | baseline to 15 minutes following device use | 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) | baseline to 15 minutes following device use | Measure change in mean arterial pressure average during baseline and 15 minutes following removal of the ITPR |
| Change From Baseline in Systolic Blood Pressure (SBP) | baseline to15 minutes following device use | Measure change in systolic blood pressure average during baseline and 15 minutes following removal of the ITPR |
| Change From Baseline in Pulse Pressure (PP) | baseline to 15 minutes following device use | 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) | baseline to 15 minutes following device use | Measure change in EtCO2 average during baseline and 15 minutes following removal of the ITPR |
| Change From Baseline in Oxygen Saturation (SpO2) | basseline to 15 minutes following device use | Measure change in SpO2 average during baseline and 15 minutes following removal of the ITPR |
| Change From Baseline in Heart Rate (HR) | baseline to 15 minutes following device use | Measure change in heart rate average during baseline and 15 minutes following removal of the ITPR |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ITPR Use of the ITPR for 120 minutes.
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. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Device deficiency | 2 |
Baseline characteristics
| Characteristic | ITPR |
|---|---|
| Age, Continuous | 44.9 years STANDARD_DEVIATION 13.1 |
| Race/Ethnicity, Customized Black | 3 Participants |
| Race/Ethnicity, Customized White | 4 Participants |
| Region of Enrollment United States | 7 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Change From Baseline in Cerebral Perfusion Pressure (CPP)
Change from average baseline CPP compared with the average CPP during use of the ITPR.
Time frame: During 120 minutes of device use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITPR | Change From Baseline in Cerebral Perfusion Pressure (CPP) | 0.0 mmHg | Standard Deviation 6.4 |
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
Time frame: baseline to 15 minutes following device use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITPR | Change From Baseline in Diastolic Blood Pressure (DBP) | 4.5 mmHg | Standard Deviation 6.3 |
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
Time frame: baseline to 15 minutes following device use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITPR | Change From Baseline in End-tidal Carbon Dioxide (EtCO2) | 0.4 mmHg | Standard Deviation 1.6 |
Secondary
Change From Baseline in Heart Rate (HR)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITPR | Change From Baseline in Heart Rate (HR) | 0.3 beats/min | Standard Deviation 6 |
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
Time frame: baseline to 15 minutes following device use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITPR | Change From Baseline in Mean Arterial Pressure (MAP) | 2.9 mmHg | Standard Deviation 12.9 |
Secondary
Change From Baseline in Oxygen Saturation (SpO2)
Measure change in SpO2 average during baseline and 15 minutes following removal of the ITPR
Time frame: basseline to 15 minutes following device use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITPR | Change From Baseline in Oxygen Saturation (SpO2) | -0.5 percentage of saturation | Standard Deviation 1.5 |
Secondary
Change From Baseline in PaCO2
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
Population: PaCO2 values for comparison were not available for two subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITPR | Change From Baseline in PaCO2 | -2.7 mmHg | Standard Deviation 3.7 |
Secondary
Change From Baseline in Pulse Pressure (PP)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITPR | Change From Baseline in Pulse Pressure (PP) | 4.9 mmHg | Standard Deviation 14.8 |
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
Time frame: baseline to15 minutes following device use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITPR | Change From Baseline in Systolic Blood Pressure (SBP) | 9.4 mmHg | Standard Deviation 18.5 |