NCT01824589

Brief Summary

The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial Perfusion Pressure (ICP) in patients with head injury and elevated ICP, and to determine the optimal ventilation tidal volume (TV).

Trial Health

10
At Risk

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_4

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 16, 2015

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

Same day

First QC Date

March 29, 2013

Results QC Date

August 25, 2014

Last Update Submit

February 12, 2015

Conditions

Head Injury

Keywords

traumatic brain injuryTBIITPRintrathoracic pressure regulatorhepatic encephalopathypseudotumorcerebriobstructive hydrocephalusintracranial hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Intracranial Pressure (ICP)

    Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.

    15 minutes after device is activated

Secondary Outcomes (3)

  • Cerebral Perfusion Pressure (CPP)

    15 minutes after device activation

  • Lung Compliance

    baseline and immediately after device removal

  • Arterial Blood Gases (PaCO2)

    15 minutes after device activation

Study Arms (4)

Group A

ACTIVE COMPARATOR

tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device

Device: -7 cm H2O ITPR

Group B

ACTIVE COMPARATOR

tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device

Device: -7 cm H2O ITPR

Group C

ACTIVE COMPARATOR

tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device

Device: -12cm H2O ITPR

Group D

ACTIVE COMPARATOR

tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device

Device: -12cm H2O ITPR

Interventions

-7 cm H2O ITPRDEVICE

Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations.

Also known as: Intrathoracic Pressure Regulator, CirQlator
Group AGroup B
-12cm H2O ITPRDEVICE

Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations.

Also known as: Intrathoracic Pressure Regulatory, CirQlator
Group CGroup D

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ≥15 years of age
  • intubated and mechanically ventilated on a volume controlled mode
  • head injury or other intracranial pathology with ICP of ≥15 mmHg
  • arterial line in place
  • SpO2 ≥95%
  • MAP \>60
  • in ICU or about to undergo neurosurgery with planned placement of an ICP monitor
  • prior written informed consent

You may not qualify if:

  • cardiac or pulmonary injury impacting intrathoracic pressure
  • confirmed pneumothorax or hemothorax
  • PaO2/FiO2 \<300
  • 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
  • congestive heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Craniocerebral TraumaBrain Injuries, TraumaticHepatic EncephalopathyHydrocephalusIntracranial Hemorrhages

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesBrain InjuriesBrain DiseasesCentral Nervous System DiseasesLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicMetabolic DiseasesNutritional and Metabolic DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

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

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2013

First Posted

April 5, 2013

Study Start

August 1, 2012

Primary Completion

August 1, 2012

Last Updated

February 16, 2015

Results First Posted

February 16, 2015

Record last verified: 2015-02