Clinical trial NCT01824576: Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion
Official title: Physiological Effects of Intrathoracic Pressure Regulation in Patients With Decreased Cerebral Perfusion Due to Brain Injury or Intracranial Pathology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head Injury
Intracranial Pathology
Compromised Cerebral Perfusion
Keywords: ITPR
CPP
TBI
traumatic brain injury
cerebral perfusion pressure
intrathoracic pressure regulator
Lead sponsor: Advanced Circulatory Systems
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2013-04-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Cerebral Perfusion Pressure (CPP)
timeFrame: During 120 minutes of device use
Secondary outcomes:
measure: Change From Baseline in Systolic Blood Pressure (SBP)
timeFrame: baseline to15 minutes following device use
measure: Change From Baseline in PaCO2
timeFrame: baseline and 15 minutes after device activation
measure: Change From Baseline in Diastolic Blood Pressure (DBP)
timeFrame: baseline to 15 minutes following device use
measure: Change From Baseline in Mean Arterial Pressure (MAP)
timeFrame: baseline to 15 minutes following device use
measure: Change From Baseline in Heart Rate (HR)
timeFrame: baseline to 15 minutes following device use
measure: Change From Baseline in Pulse Pressure (PP)
timeFrame: baseline to 15 minutes following device use
measure: Change From Baseline in End-tidal Carbon Dioxide (EtCO2)
timeFrame: baseline to 15 minutes following device use
measure: Change From Baseline in Oxygen Saturation (SpO2)
timeFrame: basseline to 15 minutes following device use
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver
state: Colorado
city: Baltimore
country: United States
facility: Baltimore
state: Maryland
Study officials:
References: