Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury

NCT ID: NCT01824589

Last Updated: 2015-02-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31

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).

Conditions

Head Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device

Group Type: ACTIVE_COMPARATOR

-7 cm H2O ITPR

Intervention Type: DEVICE

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.

Group B

tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device

Group Type: ACTIVE_COMPARATOR

-7 cm H2O ITPR

Intervention Type: DEVICE

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.

Group C

tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device

Group Type: ACTIVE_COMPARATOR

-12cm H2O ITPR

Intervention Type: DEVICE

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.

Group D

tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device

Group Type: ACTIVE_COMPARATOR

-12cm H2O ITPR

Intervention Type: DEVICE

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.

Interventions

-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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Intrathoracic Pressure Regulator, CirQlator; Intrathoracic Pressure Regulatory, CirQlator

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Advanced Circulatory Systems

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

W81XWH-11-1-0542

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ACSI W81XWH-11-1-0542

Identifier Type: -

Identifier Source: org_study_id