Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury

Head Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01824589
• Other study ID #: ACSI W81XWH-11-1-0542
• Secondary ID: W81XWH-11-1-0542
• Status: Terminated
• Phase: Phase 4
• First received: March 29, 2013
• Last updated: February 12, 2015
• Start date: August 2012

Study information

• Verified date: February 2015
• Source: Advanced Circulatory Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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%

• MAP >60

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Head Injury
• Intracranial Hypertension

Intervention

Device:
• -7 cm H2O ITPR
Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations.
• -12cm H2O ITPR
Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Advanced Circulatory Systems	U.S. Army Medical Research and Materiel Command

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial Pressure (ICP)	Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.	15 minutes after device is activated	No
Secondary	Cerebral Perfusion Pressure (CPP)	Measurement of the difference between baseline CPP and CPP at 15 minutes	15 minutes after device activation	No
Secondary	Lung Compliance	Change in lung compliance following each ITPR treatment compared to baseline.	baseline and immediately after device removal	No
Secondary	Arterial Blood Gases (PaCO2)	Arterial blood gases will be collected.	15 minutes after device activation	Yes