Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury

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

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).

Study Overview

• Status: Terminated
• Conditions: Head Injury
• Intervention / Treatment: Device: -7 cm H2O ITPR; Device: -12cm H2O ITPR

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device	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.; Other Names: Intrathoracic Pressure Regulator, CirQlator
Active Comparator: Group B; tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device	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.; Other Names: Intrathoracic Pressure Regulator, CirQlator
Active Comparator: Group C; tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device	Device: -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.; Other Names: Intrathoracic Pressure Regulatory, CirQlator
Active Comparator: Group D; tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device	Device: -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.; Other Names: Intrathoracic Pressure Regulatory, CirQlator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Advanced Circulatory Systems
• Collaborators: U.S. Army Medical Research and Development Command

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 29, 2013
• First Submitted That Met QC Criteria: April 2, 2013
• First Posted (Estimate): April 5, 2013

Study Record Updates

• Last Update Posted (Estimate): February 16, 2015
• Last Update Submitted That Met QC Criteria: February 12, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: TBI; traumatic brain injury; hepatic encephalopathy; intracranial hemorrhage; ITPR; intrathoracic pressure regulator; pseudotumorcerebri; obstructive hydrocephalus
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Craniocerebral Trauma
• Other Study ID Numbers: ACSI W81XWH-11-1-0542; W81XWH-11-1-0542 (Other Grant/Funding Number: Department of Defense)