Effects of Intrathoracic Pressure Regulation Therapy in Patients With Elevated Intracranial Pressure Due to Brain Injury or Intracranial Pathology

Advanced Circulatory Systems0 sites1 target enrollmentAugust 2012

ConditionsHead Injury

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Head Injury
Sponsor: Advanced Circulatory Systems
Enrollment: 1
Primary Endpoint: Intracranial Pressure (ICP)
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial Perfusion Pressure (ICP) in patients with head injury and elevated ICP, and to determine the optimal ventilation tidal volume (TV).

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

August 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Advanced Circulatory Systems

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•≥15 years of age
•intubated and mechanically ventilated on a volume controlled mode
•head injury or other intracranial pathology with ICP of ≥15 mmHg
•arterial line in place
•SpO2 ≥95%
•in ICU or about to undergo neurosurgery with planned placement of an ICP monitor
•inclusion presents no significant delays to planned emergent neurosurgery
•prior written informed consent

Exclusion Criteria

•cardiac or pulmonary injury impacting intrathoracic pressure
•confirmed pneumothorax or hemothorax
•PaO2/FiO2 \<300
•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
•congestive heart failure