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Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion (4hour)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02388880
Recruitment Status : Terminated (Slower than anticipated enrollment)
First Posted : March 17, 2015
Results First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
United States Army Institute of Surgical Research
Information provided by (Responsible Party):
Advanced Circulatory Systems

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Head Injury
Intracranial Pathology
Compromised Cerebral Perfusion
Intervention Device: ITPR
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ITPR
Hide Arm/Group Description

Use of the ITPR for 240 minutes.

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.

Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title ITPR
Hide Arm/Group Description

Use of the ITPR for 240 minutes.

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.

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
29.67  (18.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
0
   0.0%
Male
3
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
3
 100.0%
Not Hispanic or Latino
0
   0.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
3
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Cerebral Perfusion Pressure (CPP)
Hide Description Change from baseline CPP compared with the CPP during use of the ITPR.
Time Frame During 240 minutes of device use
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ITPR
Hide Arm/Group Description:

Use of the ITPR for 240 minutes.

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.

Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: mmHg
-4.88  (6.29)
2.Secondary Outcome
Title Mean Arterial Pressure (MAP)
Hide Description Change from baseline MAP compared with the MAP during use of the ITPR.
Time Frame baseline to end of ITPR use
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ITPR
Hide Arm/Group Description:

Use of the ITPR for 240 minutes.

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.

Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: mmHg
-4.08  (14.5)
3.Secondary Outcome
Title Intracranial Pressure (ICP)
Hide Description Change from baseline ICP compared with the ICP during use of the ITPR.
Time Frame baseline to end of ITPR use
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ITPR
Hide Arm/Group Description:

Use of the ITPR for 240 minutes.

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.

Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: mmHg
1.05  (9.63)
4.Secondary Outcome
Title End-tidal Carbon Dioxide (EtCO2)
Hide Description Change from baseline EtCO2 compared with the EtCO2 during use of the ITPR.
Time Frame baseline to end of ITPR use
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ITPR
Hide Arm/Group Description:

Use of the ITPR for 240 minutes.

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.

Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: mmHg
0.42  (7.07)
Time Frame Duration of device use.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ITPR
Hide Arm/Group Description

Use of the ITPR for 240 minutes.

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.

All-Cause Mortality
ITPR
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
ITPR
Affected / at Risk (%) # Events
Total   2/3 (66.67%)    
Vascular disorders   
Increase in ICP >10mmHg *  1/3 (33.33%)  1
Decrease in MAP >20mmHg *  1/3 (33.33%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ITPR
Affected / at Risk (%) # Events
Total   1/3 (33.33%)    
Respiratory, thoracic and mediastinal disorders   
Desaturation *  1/3 (33.33%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Research Associate
Organization: Advanced Circulatory Systems
Phone: 651.403.5600
EMail: nburkhart@advancedcirculatory.com
Layout table for additonal information
Responsible Party: Advanced Circulatory Systems
ClinicalTrials.gov Identifier: NCT02388880    
Other Study ID Numbers: ACSI 450-0003
W81XWH-12-C-0181 ( Other Grant/Funding Number: United States Army Institute for Surgical Research )
First Submitted: March 10, 2015
First Posted: March 17, 2015
Results First Submitted: March 27, 2019
Results First Posted: April 22, 2019
Last Update Posted: April 22, 2019