Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury

Advanced Circulatory Systems

Status and phase: Terminated; Phase 4

Conditions: Head Injury

Treatments: Device: -12cm H2O ITPR; Device: -7 cm H2O ITPR

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT01824589

W81XWH-11-1-0542 (Other Grant/Funding Number)

ACSI W81XWH-11-1-0542

Details and patient eligibility

About

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).

Enrollment: 1 patient

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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1 participants in 4 patient groups

Group A

Active Comparator group

Description:

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

Treatment:

Device: -7 cm H2O ITPR

Group B

Active Comparator group

Description:

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

Treatment:

Device: -7 cm H2O ITPR

Group C

Active Comparator group

Description:

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

Treatment:

Device: -12cm H2O ITPR

Group D

Active Comparator group

Description:

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

Treatment:

Device: -12cm H2O ITPR