Head Injury
Conditions
Keywords
traumatic brain injury, TBI, ITPR, intrathoracic pressure regulator, hepatic encephalopathy, pseudotumorcerebri, obstructive hydrocephalus, intracranial hemorrhage
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).
Interventions
DEVICE-7 cm H2O ITPR
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.
DEVICE-12cm H2O ITPR
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.
Sponsors
U.S. Army Medical Research and Development Command
Advanced Circulatory Systems
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intracranial Pressure (ICP) | 15 minutes after device is activated | Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Perfusion Pressure (CPP) | 15 minutes after device activation | Measurement of the difference between baseline CPP and CPP at 15 minutes |
| Lung Compliance | baseline and immediately after device removal | Change in lung compliance following each ITPR treatment compared to baseline. |
| Arterial Blood Gases (PaCO2) | 15 minutes after device activation | Arterial blood gases will be collected. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device
-7 cm H2O ITPR: 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. | 1 |
| Group B tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device
-7 cm H2O ITPR: 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. | 0 |
| Group C tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device
-12cm H2O ITPR: 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. | 0 |
| Group D tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device
-12cm H2O ITPR: 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. | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Group A | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants |
| Age, Categorical >=65 years | 1 participants | 1 participants |
| Age, Categorical Between 18 and 65 years | 0 participants | 0 participants |
| Gender Female | 0 participants | 0 participants |
| Gender Male | 1 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Intracranial Pressure (ICP)
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Intracranial Pressure (ICP) | 6ml/kg; -7cmH2O | -1 mmHg |
| Group A | Intracranial Pressure (ICP) | 8ml/kg; -7cmH2O | -1 mmHg |
| Group A | Intracranial Pressure (ICP) | 8ml/kg; -12cmH2O | 4 mmHg |
| Group A | Intracranial Pressure (ICP) | 6ml/kg; -12cmH2O | NA mmHg |
Secondary
Arterial Blood Gases (PaCO2)
Arterial blood gases will be collected.
Time frame: 15 minutes after device activation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Arterial Blood Gases (PaCO2) | 6ml/kg; -7cmH2O | 45.0 mmHg |
| Group A | Arterial Blood Gases (PaCO2) | 8ml/kg; -7cmH2O | 44.7 mmHg |
| Group A | Arterial Blood Gases (PaCO2) | 8ml/kg; -12cmH2O | 44.4 mmHg |
| Group A | Arterial Blood Gases (PaCO2) | 6ml/kg; -12cmH2O | NA mmHg |
Secondary
Cerebral Perfusion Pressure (CPP)
Measurement of the difference between baseline CPP and CPP at 15 minutes
Time frame: 15 minutes after device activation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Cerebral Perfusion Pressure (CPP) | 6ml/kg; -7cmH2O | -1 mmHg |
| Group A | Cerebral Perfusion Pressure (CPP) | 8ml/kg; -7cmH2O | 1 mmHg |
| Group A | Cerebral Perfusion Pressure (CPP) | 8ml/kg; -12cmH2O | -5 mmHg |
| Group A | Cerebral Perfusion Pressure (CPP) | 6ml/kg; -12cmH2O | NA mmHg |
Secondary
Lung Compliance
Change in lung compliance following each ITPR treatment compared to baseline.
Time frame: baseline and immediately after device removal
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Lung Compliance | 6ml/kg; -7cmH2O | 5.6 ml/cmH2O |
| Group A | Lung Compliance | 8ml/kg; -7cmH2O | 3.3 ml/cmH2O |
| Group A | Lung Compliance | 8ml/kg; -12cmH2O | -0.7 ml/cmH2O |
| Group A | Lung Compliance | 6ml/kg; -12cmH2O | NA ml/cmH2O |