NCT01824576

Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion

Physiological Effects of Intrathoracic Pressure Regulation in Patients With Decreased Cerebral Perfusion Due to Brain Injury or Intracranial Pathology

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Advanced Circulatory Systems · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head Injury
• Intracranial Pathology
• Compromised Cerebral Perfusion

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2013-04-05
• Last updated: 2017-09-27
• Results posted: 2017-09-27

Locations

2 sites across 1 country: United States