Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion

Advanced Circulatory Systems9 enrolled

Overview

The purpose of the study is to evaluate the physiological response to application of the Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation. The study will evaluate the physiological response to intrathoracic pressure regulation (IPR) therapy in hemodynamically stable patients with compromised cerebral circulation who are on ventilatory support.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head Injury Intracranial Pathology Compromised Cerebral Perfusion

Interventions

ITPRDEVICE

Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥18 years of age * intubated and mechanically ventilated on a volume controlled mode * head injury or other intracranial pathology and compromised cerebral perfusion * arterial line in place or alternative with continuous pressure monitoring * SpO2 ≥90% * mean arterial pressure \>55 * admission to ICU or about to undergo neurosurgery with planned placement of an invasive intracranial pressure monitor * inclusion presents no significant delays to planned emergent neurosurgery * prior written informed consent Exclusion Criteria: * cardiac or pulmonary injury * confirmed pneumothorax or hemothorax * 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 * marked hypertension at time of device use defined as systolic blood pressure \>180 mmHg * congestive heart failure * women with positive serum or urine pregnancy test or breast feeding

Locations (2)

Denver

Denver, Colorado, United States

Baltimore

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Change From Baseline in Cerebral Perfusion Pressure (CPP)

Change from average baseline CPP compared with the average CPP during use of the ITPR.

Time frame: During 120 minutes of device use

Secondary Outcomes

Change From Baseline in Systolic Blood Pressure (SBP)

Measure change in systolic blood pressure average during baseline and 15 minutes following removal of the ITPR

Time frame: baseline to15 minutes following device use

Change From Baseline in PaCO2

PaCO2 will be collected during baseline and 15 minutes after device activation and change will be evaluated.

Time frame: baseline and 15 minutes after device activation

Change From Baseline in Diastolic Blood Pressure (DBP)

Measure change in diastolic blood pressure average during baseline and 15 minutes following removal of the ITPR

Time frame: baseline to 15 minutes following device use

Change From Baseline in Mean Arterial Pressure (MAP)

Measure change in mean arterial pressure average during baseline and 15 minutes following removal of the ITPR

Time frame: baseline to 15 minutes following device use

Change From Baseline in Heart Rate (HR)

Measure change in heart rate average during baseline and 15 minutes following removal of the ITPR

Time frame: baseline to 15 minutes following device use

Change From Baseline in Pulse Pressure (PP)

Measure change in pulse pressure average during baseline and 15 minutes following removal of the ITPR

Data from ClinicalTrials.gov

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