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Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury

Primary Purpose

Head Injury

Status

Terminated

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

-7 cm H2O ITPR

-12cm H2O ITPR

About this trial

This is an interventional treatment trial for Head Injury focused on measuring traumatic brain injury, TBI, ITPR, intrathoracic pressure regulator, hepatic encephalopathy, pseudotumorcerebri, obstructive hydrocephalus, intracranial hemorrhage

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

≥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
inclusion presents no significant delays to planned emergent neurosurgery
prior written informed consent

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Group A

Group B

Group C

Group D

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Intracranial Pressure (ICP)

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

Secondary Outcome Measures

Cerebral Perfusion Pressure (CPP)

Measurement of the difference between baseline CPP and CPP at 15 minutes

Lung Compliance

Change in lung compliance following each ITPR treatment compared to baseline.

Arterial Blood Gases (PaCO2)

Arterial blood gases will be collected.

Full Information

NCT ID

NCT01824589

First Posted

March 29, 2013

Last Updated

February 12, 2015

Sponsor

Advanced Circulatory Systems

Collaborators

U.S. Army Medical Research and Development Command

1. Study Identification

Unique Protocol Identification Number

NCT01824589

Brief Title

Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury

Official Title

Effects of Intrathoracic Pressure Regulation Therapy in Patients With Elevated Intracranial Pressure Due to Brain Injury or Intracranial Pathology

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Terminated

Study Start Date

August 2012 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Advanced Circulatory Systems

Collaborators

U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head Injury

Keywords

traumatic brain injury, TBI, ITPR, intrathoracic pressure regulator, hepatic encephalopathy, pseudotumorcerebri, obstructive hydrocephalus, intracranial hemorrhage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group C

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group D

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

-7 cm H2O ITPR

Other Intervention Name(s)

Intrathoracic Pressure Regulator, CirQlator

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

-12cm H2O ITPR

Other Intervention Name(s)

Intrathoracic Pressure Regulatory, CirQlator

Intervention Description

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.

Primary Outcome Measure Information:

Title

Intracranial Pressure (ICP)

Description

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

Time Frame

15 minutes after device is activated

Secondary Outcome Measure Information:

Title

Cerebral Perfusion Pressure (CPP)

Description

Measurement of the difference between baseline CPP and CPP at 15 minutes

Time Frame

15 minutes after device activation

Title

Lung Compliance

Description

Change in lung compliance following each ITPR treatment compared to baseline.

Time Frame

baseline and immediately after device removal

Title

Arterial Blood Gases (PaCO2)

Description

Arterial blood gases will be collected.

Time Frame

15 minutes after device activation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥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 inclusion presents no significant delays to planned emergent neurosurgery prior written informed consent Exclusion Criteria: 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

12. IPD Sharing Statement

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Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury

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