Trial Outcomes & Findings for Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion (4hour) (NCT NCT02388880)

NCT ID: NCT02388880

Last Updated: 2019-04-22

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 3 participants
• Primary outcome timeframe: During 240 minutes of device use
• Results posted on: 2019-04-22

Participant Flow

Participant milestones

Measure	ITPR 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 Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	ITPR n=3 Participants 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.
Age, Continuous	29.67 years STANDARD_DEVIATION 18.50 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: During 240 minutes of device use

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

Outcome measures

Measure	ITPR n=3 Participants 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.
Cerebral Perfusion Pressure (CPP)	-4.88 mmHg Standard Deviation 6.29

SECONDARY outcome

Timeframe: baseline to end of ITPR use

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

Outcome measures

Measure	ITPR n=3 Participants 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.
Mean Arterial Pressure (MAP)	-4.08 mmHg Standard Deviation 14.5

SECONDARY outcome

Timeframe: baseline to end of ITPR use

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

Outcome measures

Measure	ITPR n=3 Participants 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.
Intracranial Pressure (ICP)	1.05 mmHg Standard Deviation 9.63

SECONDARY outcome

Timeframe: baseline to end of ITPR use

Change from baseline EtCO2 compared with the EtCO2 during use of the ITPR.

Outcome measures

Measure	ITPR n=3 Participants 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.
End-tidal Carbon Dioxide (EtCO2)	0.42 mmHg Standard Deviation 7.07

Adverse Events

ITPR

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	ITPR n=3 participants at risk 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.
Vascular disorders Increase in ICP >10mmHg	33.3% 1/3 • Number of events 1 • Duration of device use.
Vascular disorders Decrease in MAP >20mmHg	33.3% 1/3 • Number of events 1 • Duration of device use.

Other adverse events

Measure	ITPR n=3 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Desaturation	33.3% 1/3 • Number of events 1 • Duration of device use.

Additional Information

Clinical Research Associate

Advanced Circulatory Systems

Phone: 651.403.5600

Email: nburkhart@advancedcirculatory.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60