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

Advanced Circulatory Systems

Status

Terminated

Conditions

Head Injury

Intracranial Pathology

Compromised Cerebral Perfusion

Treatments

Device: ITPR

Study type

Interventional

Funder types

Industry

Other U.S. Federal agency

Identifiers

NCT02388880

W81XWH-12-C-0181 (Other Grant/Funding Number)

ACSI 450-0003

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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