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Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion (4hour)

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ClinicalTrials.gov Identifier: NCT02388880
Recruitment Status : Terminated (Slower than anticipated enrollment)
First Posted : March 17, 2015
Results First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
United States Army Institute of Surgical Research
Information provided by (Responsible Party):
Advanced Circulatory Systems

Tracking Information
First Submitted Date  ICMJE March 10, 2015
First Posted Date  ICMJE March 17, 2015
Results First Submitted Date  ICMJE March 27, 2019
Results First Posted Date  ICMJE April 22, 2019
Last Update Posted Date April 22, 2019
Study Start Date  ICMJE February 2015
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
Cerebral Perfusion Pressure (CPP) [ Time Frame: During 240 minutes of device use ]
Change from baseline CPP compared with the CPP during use of the ITPR.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2019)
  • Mean Arterial Pressure (MAP) [ Time Frame: baseline to end of ITPR use ]
    Change from baseline MAP compared with the MAP during use of the ITPR.
  • Intracranial Pressure (ICP) [ Time Frame: baseline to end of ITPR use ]
    Change from baseline ICP compared with the ICP during use of the ITPR.
  • End-tidal Carbon Dioxide (EtCO2) [ Time Frame: baseline to end of ITPR use ]
    Change from baseline EtCO2 compared with the EtCO2 during use of the ITPR.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
  • systolic blood pressure (SBP) [ Time Frame: baseline to15 minutes following device use ]
    Measure change in systolic blood pressure at baseline, during ITPR treatment, and 15 minutes following removal of the ITPR
  • Arterial blood gases [ Time Frame: baseline and 15 minutes after device activation ]
    Arterial blood gases will be collected immediately following each study intervention and change will be evaluated.
  • Diastolic blood pressure (DBP) [ Time Frame: baseline to 15 minutes following device use ]
    Measure change in diastolic blood pressure at baseline, during ITPR treatment, and 15 minutes following removal of the ITPR
  • Mean Arterial Pressure (MAP) [ Time Frame: baseline to 15 minutes following device use ]
    Measure change in mean arterial pressure at baseline, during ITPR treatment, and 15 minutes following removal of the ITPR
  • Heart rate (HR) [ Time Frame: baseline to 15 minutes following device use ]
    Measure change in heart rate at baseline, during ITPR treatment, and 15 minutes following removal of the ITPR
  • Pulse pressure (PP) [ Time Frame: baseline to 15 minutes following device use ]
    Measure change in pulse pressure at baseline, during ITPR treatment, and 15 minutes following removal of the ITPR
  • End-tidal Carbon Dioxide (EtCO2) [ Time Frame: baseline to 15 minutes following device use ]
    Measure change in EtCO2 at baseline, during ITPR treatment, and 15 minutes following removal of the ITPR
  • Oxygen saturation (SpO2) [ Time Frame: basseline to 15 minutes following device use ]
    Measure change in SpO2 at baseline, during ITPR treatment, and 15 minutes following removal of the ITPR
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion (4hour)
Official Title  ICMJE Physiological Effects of Intrathoracic Pressure Regulation in Patients With Decreased Cerebral Perfusion Due to Brain Injury or Intracranial Pathology (4 Hour Use)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Head Injury
  • Intracranial Pathology
  • Compromised Cerebral Perfusion
Intervention  ICMJE Device: 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 Names:
  • Intrathoracic Pressure Regulator
  • CirQlator
Study Arms  ICMJE Experimental: ITPR
Use of the ITPR for 240 minutes.
Intervention: Device: ITPR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 27, 2019)
3
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2015)
30
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02388880
Other Study ID Numbers  ICMJE ACSI 450-0003
W81XWH-12-C-0181 ( Other Grant/Funding Number: United States Army Institute for Surgical Research )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Advanced Circulatory Systems
Study Sponsor  ICMJE Advanced Circulatory Systems
Collaborators  ICMJE United States Army Institute of Surgical Research
Investigators  ICMJE Not Provided
PRS Account Advanced Circulatory Systems
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP