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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01205607 |
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Date of registration:
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17/09/2010 |
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Primary sponsor: |
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Public title:
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IRB-HSR# 14299: The Use of the Intrathoracic Pressure Regulator (ITPR) to Improve Cerebral Perfusion Pressure in Patients With Altered Intracranial Elastance
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Scientific title:
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IRB-HSR# 14299: The Use of the Intrathoracic Pressure Regulator (ITPR) to Improve Cerebral Perfusion Pressure in Patients With Altered Intracranial Elastance |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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20 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT01205607 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research
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Countries of recruitment
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United States
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Contacts
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Name:
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Edward C Nemergfut, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Virginia Anesthesiology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 1. patients who have a functioning intracranial pressure-monitoring device (either a
subarachnoid bolt, or an intraventricular catheter) in place, and are either sedated,
intubated, and mechanically ventilated (i.e. in the NNICU)and have an arterial line
in place, or are scheduled to undergo an operation or interventional
neuroradiological procedure at the University of Virginia.
2. age 18 years of age and older 3. informed consent/ surrogate consent has been
obtained
Exclusion Criteria:
- 1. pneumothorax 2. hemothroax 3. uncontrolled bleeding 4. uncontrolled hypertension
defined as SBP > 180 mmHg at the time of surgery 5. known respiratory disease such
as chronic emphysema, COPD, or Cystic Fibrosis
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Traumatic Brain Injury
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Intervention(s)
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Device: ITPR -5 mm Hg then -9 mm Hg
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Device: ITPR -9 & then -5mm Hg
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Primary Outcome(s)
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Hemodynamic variables
[Time Frame: baseline, 5 minutes after device activation & 5 minutes after device turned off]
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Secondary Outcome(s)
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cardiac performance
[Time Frame: baseline, 5 minutes after device activation & 5 minutes after device turned off]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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