Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion

NCT01824576 | Terminated Results

• 2 other identifiers: ACSI 5R44NS0543725R44NS054372
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Head Injury; Intracranial Pathology; Compromised Cerebral Perfusion

Keywords

ITPR; CPP; TBI; traumatic brain injury; cerebral perfusion pressure; intrathoracic pressure regulator

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Cerebral Perfusion Pressure (CPP)

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

  During 120 minutes of device use

Secondary Outcomes (8)

• Change From Baseline in Systolic Blood Pressure (SBP)

  baseline to15 minutes following device use

• Change From Baseline in PaCO2

  baseline and 15 minutes after device activation

• Change From Baseline in Diastolic Blood Pressure (DBP)

  baseline to 15 minutes following device use

• Change From Baseline in Mean Arterial Pressure (MAP)

  baseline to 15 minutes following device use

• Change From Baseline in Heart Rate (HR)

  baseline to 15 minutes following device use

Study Arms (1)

ITPR

EXPERIMENTAL

Use of the ITPR for 120 minutes.

Device: ITPR

Interventions

ITPR DEVICE

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.

Also known as: Intrathoracic Pressure Regulator, CirQlator

ITPR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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
• prior written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Advanced Circulatory Systems: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

Denver

Denver, Colorado, United States

Location

Baltimore

Baltimore, Maryland, United States

Location

MeSH Terms

Conditions

Craniocerebral Trauma; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Brain Injuries; Brain Diseases; Central Nervous System Diseases

Results Point of Contact

• Title: Sr. Clinical Research Associate
• Organization: Advanced Circulatory

nburkhart@zoll.com

651.403.5606

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2013
• First Posted: April 5, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: September 27, 2017
• Results First Posted: September 27, 2017

Record last verified: 2017-08

Locations

US (2)