Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion
NCT ID: NCT01824576
Last Updated: 2017-09-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
9 participants
INTERVENTIONAL
2013-04-30
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Advanced Circulatory Systems
INDUSTRY
Responsible Party
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Locations
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Denver
Denver, Colorado, United States
Baltimore
Baltimore, Maryland, United States
Countries
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Other Identifiers
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ACSI 5R44NS054372
Identifier Type: -
Identifier Source: org_study_id