Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury

Phase 4TerminatedNCT01824589

Advanced Circulatory Systems1 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Head Injury

Interventions

-7 cm H2O ITPRDEVICE

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 ITPRDEVICE

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.

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Intracranial Pressure (ICP)

Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.

Time frame: 15 minutes after device is activated

Secondary Outcomes

Cerebral Perfusion Pressure (CPP)

Measurement of the difference between baseline CPP and CPP at 15 minutes

Time frame: 15 minutes after device activation

Lung Compliance

Change in lung compliance following each ITPR treatment compared to baseline.

Time frame: baseline and immediately after device removal

Arterial Blood Gases (PaCO2)

Arterial blood gases will be collected.

Time frame: 15 minutes after device activation

Data from ClinicalTrials.gov

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