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

Last updated: March 27, 2019
Sponsor: Advanced Circulatory Systems
Overall Status: Terminated

Phase

N/A

Condition

Brain Injury

Treatment

N/A

Clinical Study ID

NCT02388880
ACSI 450-0003
W81XWH-12-C-0181
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 aninvasive intracranial pressure monitor

  • inclusion presents no significant delays to planned emergent neurosurgery

  • prior written informed consent

Exclusion

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 orpulmonary 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

Study Design

Total Participants: 3
Study Start date:
February 01, 2015
Estimated Completion Date:
November 30, 2016

Connect with a study center

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

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