Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury

Phase 4

Terminated

• Conditions: Head Injury
• Interventions: Device: -7 cm H2O ITPR; Device: -12cm H2O ITPR

• Registration Number: NCT01824589
• Lead Sponsor: Advanced Circulatory Systems

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-08
• Study First Submitted: 2013-03-29
• Study First Submitted QC: 2013-04-02
• Study First Posted: 2013-04-05
• Results First Submitted: 2014-08-25
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-12
• Last Update Submitted: 2015-02-12
• Results First Posted: 2015-02-16
• Last Update Posted: 2015-02-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	-7 cm H2O ITPR	tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device
Group A	-7 cm H2O ITPR	tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device
Group D	-12cm H2O ITPR	tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device
Group C	-12cm H2O ITPR	tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device

Primary Outcome Measures

Name	Time	Method
Intracranial Pressure (ICP)	15 minutes after device is activated	Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.

Secondary Outcome Measures

Name	Time	Method
Cerebral Perfusion Pressure (CPP)	15 minutes after device activation	Measurement of the difference between baseline CPP and CPP at 15 minutes
Lung Compliance	baseline and immediately after device removal	Change in lung compliance following each ITPR treatment compared to baseline.
Arterial Blood Gases (PaCO2)	15 minutes after device activation	Arterial blood gases will be collected.