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
United States Army Institute of Surgical Research
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 |
|---|---|---|
| Cerebral Perfusion Pressure (CPP) | During 240 minutes of device use | Change from baseline CPP compared with the CPP during use of the ITPR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intracranial Pressure (ICP) | baseline to end of ITPR use | Change from baseline ICP compared with the ICP during use of the ITPR. |
| Mean Arterial Pressure (MAP) | baseline to end of ITPR use | Change from baseline MAP compared with the MAP during use of the ITPR. |
| End-tidal Carbon Dioxide (EtCO2) | baseline to end of ITPR use | Change from baseline EtCO2 compared with the EtCO2 during use of the ITPR. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ITPR Use of the ITPR for 240 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. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | ITPR |
|---|---|
| Age, Continuous | 29.67 years STANDARD_DEVIATION 18.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 3 |
| serious Total, serious adverse events | 2 / 3 |
Outcome results
Primary
Cerebral Perfusion Pressure (CPP)
Change from baseline CPP compared with the CPP during use of the ITPR.
Time frame: During 240 minutes of device use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITPR | Cerebral Perfusion Pressure (CPP) | -4.88 mmHg | Standard Deviation 6.29 |
Secondary
End-tidal Carbon Dioxide (EtCO2)
Change from baseline EtCO2 compared with the EtCO2 during use of the ITPR.
Time frame: baseline to end of ITPR use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITPR | End-tidal Carbon Dioxide (EtCO2) | 0.42 mmHg | Standard Deviation 7.07 |
Secondary
Intracranial Pressure (ICP)
Change from baseline ICP compared with the ICP during use of the ITPR.
Time frame: baseline to end of ITPR use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITPR | Intracranial Pressure (ICP) | 1.05 mmHg | Standard Deviation 9.63 |
Secondary
Mean Arterial Pressure (MAP)
Change from baseline MAP compared with the MAP during use of the ITPR.
Time frame: baseline to end of ITPR use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITPR | Mean Arterial Pressure (MAP) | -4.08 mmHg | Standard Deviation 14.5 |