Trial Outcomes & Findings for Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury (NCT NCT01824589)
NCT ID: NCT01824589
Last Updated: 2015-02-16
Results Overview
Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
1 participants
Primary outcome timeframe
15 minutes after device is activated
Results posted on
2015-02-16
Participant Flow
Participant milestones
| Measure |
Group A
no device (washout) with tidal volume setting of 6ml/kg for 20 minutes, then 6ml/kg with the -7cm H2O ITPR as first device for 15 minutes, then tidal volume increased to 8ml/kg with the -7cm H2O ITPR for 15 minutes, then no device with 8ml/kg for 20 minutes, then 8ml/kg with -12cm H2O ITPR for 15 minutes, then 6ml/kg with -12cm H2O ITPR for 15 minutes, then no device with 6ml/kg.
-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.
|
Group B
no device (washout) with tidal volume setting of 8ml/kg for 20 minutes, then 8ml/kg with the -7cm H2O ITPR as first device for 15 minutes, then tidal volume decreased to 6ml/kg with the -7cm H2O ITPR for 15 minutes, then no device with 6ml/kg for 20 minutes, then 6ml/kg with -12cm H2O ITPR for 15 minutes, then 8ml/kg with -12cm H2O ITPR for 15 minutes, then no device with 8ml/kg.
-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.
|
Group C
no device (washout) with tidal volume setting of 6ml/kg for 20 minutes, then 6ml/kg with the -12cm H2O ITPR as first device for 15 minutes, then tidal volume increased to 8ml/kg with the -12cm H2O ITPR for 15 minutes, then no device with 8ml/kg for 20 minutes, then 8ml/kg with -7cm H2O ITPR for 15 minutes, then 6ml/kg with -7cm H2O ITPR for 15 minutes, then no device with 6ml/kg.
-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.
|
Group D
no device (washout) with tidal volume setting of 8ml/kg for 20 minutes, then 8ml/kg with the -12cm H2O ITPR as first device for 15 minutes, then tidal volume decreased to 6ml/kg with the -12cm H2O ITPR for 15 minutes, then no device with 6ml/kg for 20 minutes, then 6ml/kg with -7cm H2O ITPR for 15 minutes, then 8ml/kg with -7cm H2O ITPR for 15 minutes, then no device with 8ml/kg.
-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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
Group A
n=1 Participants
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.
|
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.
|
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.
|
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.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=5 Participants
|
—
|
—
|
—
|
0 participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 participants
n=5 Participants
|
—
|
—
|
—
|
0 participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 participants
n=5 Participants
|
—
|
—
|
—
|
1 participants
n=21 Participants
|
|
Gender
Female
|
0 participants
n=5 Participants
|
—
|
—
|
—
|
0 participants
n=21 Participants
|
|
Gender
Male
|
1 participants
n=5 Participants
|
—
|
—
|
—
|
1 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 15 minutes after device is activatedChange in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.
Outcome measures
| Measure |
Group A
n=1 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Intracranial Pressure (ICP)
6ml/kg; -7cmH2O
|
-1 mmHg
|
—
|
—
|
—
|
|
Intracranial Pressure (ICP)
8ml/kg; -7cmH2O
|
-1 mmHg
|
—
|
—
|
—
|
|
Intracranial Pressure (ICP)
8ml/kg; -12cmH2O
|
4 mmHg
|
—
|
—
|
—
|
|
Intracranial Pressure (ICP)
6ml/kg; -12cmH2O
|
NA mmHg
Protocol discontinued after 8ml/kg with -12cmH2O device as patient was not tolerating device
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 minutes after device activationMeasurement of the difference between baseline CPP and CPP at 15 minutes
Outcome measures
| Measure |
Group A
n=1 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Cerebral Perfusion Pressure (CPP)
6ml/kg; -7cmH2O
|
-1 mmHg
|
—
|
—
|
—
|
|
Cerebral Perfusion Pressure (CPP)
8ml/kg; -7cmH2O
|
1 mmHg
|
—
|
—
|
—
|
|
Cerebral Perfusion Pressure (CPP)
8ml/kg; -12cmH2O
|
-5 mmHg
|
—
|
—
|
—
|
|
Cerebral Perfusion Pressure (CPP)
6ml/kg; -12cmH2O
|
NA mmHg
Protocol discontinued after 8ml/kg with -12cmH2O due to patient not tolerating device
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and immediately after device removalChange in lung compliance following each ITPR treatment compared to baseline.
Outcome measures
| Measure |
Group A
n=1 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Lung Compliance
6ml/kg; -7cmH2O
|
5.6 ml/cmH2O
|
—
|
—
|
—
|
|
Lung Compliance
8ml/kg; -7cmH2O
|
3.3 ml/cmH2O
|
—
|
—
|
—
|
|
Lung Compliance
8ml/kg; -12cmH2O
|
-0.7 ml/cmH2O
|
—
|
—
|
—
|
|
Lung Compliance
6ml/kg; -12cmH2O
|
NA ml/cmH2O
Protocol discontinued after 8ml/kg with -12cmH2O device as patient was no longer able to tolerate device
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 minutes after device activationArterial blood gases will be collected.
Outcome measures
| Measure |
Group A
n=1 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Arterial Blood Gases (PaCO2)
6ml/kg; -7cmH2O
|
45.0 mmHg
|
—
|
—
|
—
|
|
Arterial Blood Gases (PaCO2)
8ml/kg; -7cmH2O
|
44.7 mmHg
|
—
|
—
|
—
|
|
Arterial Blood Gases (PaCO2)
8ml/kg; -12cmH2O
|
44.4 mmHg
|
—
|
—
|
—
|
|
Arterial Blood Gases (PaCO2)
6ml/kg; -12cmH2O
|
NA mmHg
Protocol discontinued after 8ml/kg with -12cmH2O device as patient was no longer able to tolerate device
|
—
|
—
|
—
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place