NCT02388880

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

April 22, 2019

Completed
Last Updated

April 22, 2019

Status Verified

March 1, 2019

Enrollment Period

1.8 years

First QC Date

March 10, 2015

Results QC Date

March 27, 2019

Last Update Submit

March 27, 2019

Conditions

Head InjuryIntracranial PathologyCompromised Cerebral Perfusion

Keywords

ITPRCPPTBItraumatic brain injurycerebral perfusion pressureintrathoracic pressure regulator

Outcome Measures

Primary Outcomes (1)

  • Cerebral Perfusion Pressure (CPP)

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

    During 240 minutes of device use

Secondary Outcomes (3)

  • Mean Arterial Pressure (MAP)

    baseline to end of ITPR use

  • Intracranial Pressure (ICP)

    baseline to end of ITPR use

  • End-tidal Carbon Dioxide (EtCO2)

    baseline to end of ITPR use

Study Arms (1)

ITPR

EXPERIMENTAL

Use of the ITPR for 240 minutes.

Device: ITPR

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.

Also known as: Intrathoracic Pressure Regulator, CirQlator
ITPR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Craniocerebral TraumaBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesBrain InjuriesBrain DiseasesCentral Nervous System Diseases

Results Point of Contact

Title
Clinical Research Associate
Organization
Advanced Circulatory Systems
nburkhart@advancedcirculatory.com
651.403.5600

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

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 10, 2015

First Posted

March 17, 2015

Study Start

February 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

April 22, 2019

Results First Posted

April 22, 2019

Record last verified: 2019-03

Locations

US(1)