Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion

August 30, 2017 updated by: Advanced Circulatory Systems

Physiological Effects of Intrathoracic Pressure Regulation in Patients With Decreased Cerebral Perfusion Due to Brain Injury or Intracranial Pathology

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States
        • Denver
    • Maryland
      • Baltimore, Maryland, United States
        • Baltimore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ITPR
Use of the ITPR for 120 minutes.
Device: ITPR
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.
Other Names:
  • Intrathoracic Pressure Regulator
  • CirQlator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Cerebral Perfusion Pressure (CPP)
Time Frame: During 120 minutes of device use
Change from average baseline CPP compared with the average CPP during use of the ITPR.
During 120 minutes of device use

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Systolic Blood Pressure (SBP)
Time Frame: baseline to15 minutes following device use
Measure change in systolic blood pressure average during baseline and 15 minutes following removal of the ITPR
baseline to15 minutes following device use
Change From Baseline in PaCO2
Time Frame: baseline and 15 minutes after device activation
PaCO2 will be collected during baseline and 15 minutes after device activation and change will be evaluated.
baseline and 15 minutes after device activation
Change From Baseline in Diastolic Blood Pressure (DBP)
Time Frame: baseline to 15 minutes following device use
Measure change in diastolic blood pressure average during baseline and 15 minutes following removal of the ITPR
baseline to 15 minutes following device use
Change From Baseline in Mean Arterial Pressure (MAP)
Time Frame: baseline to 15 minutes following device use
Measure change in mean arterial pressure average during baseline and 15 minutes following removal of the ITPR
baseline to 15 minutes following device use
Change From Baseline in Heart Rate (HR)
Time Frame: baseline to 15 minutes following device use
Measure change in heart rate average during baseline and 15 minutes following removal of the ITPR
baseline to 15 minutes following device use
Change From Baseline in Pulse Pressure (PP)
Time Frame: baseline to 15 minutes following device use
Measure change in pulse pressure average during baseline and 15 minutes following removal of the ITPR
baseline to 15 minutes following device use
Change From Baseline in End-tidal Carbon Dioxide (EtCO2)
Time Frame: baseline to 15 minutes following device use
Measure change in EtCO2 average during baseline and 15 minutes following removal of the ITPR
baseline to 15 minutes following device use
Change From Baseline in Oxygen Saturation (SpO2)
Time Frame: basseline to 15 minutes following device use
Measure change in SpO2 average during baseline and 15 minutes following removal of the ITPR
basseline to 15 minutes following device use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Advanced Circulatory Systems

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Neurological Disorders and Stroke (NINDS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACSI 5R44NS054372
  • 5R44NS054372 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings