Trial Outcomes & Findings for Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion (NCT NCT01824576)

NCT ID: NCT01824576

Last Updated: 2017-09-27

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: During 120 minutes of device use
• Results posted on: 2017-09-27

Participant Flow

Participant milestones

Measure	ITPR Use of the ITPR for 120 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	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	ITPR Use of the ITPR for 120 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 Device deficiency	2

Baseline Characteristics

Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion

Baseline characteristics by cohort

Measure	ITPR n=7 Participants Use of the ITPR for 120 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	44.9 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: During 120 minutes of device use

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

Outcome measures

Measure	ITPR n=7 Participants Use of the ITPR for 120 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.
Change From Baseline in Cerebral Perfusion Pressure (CPP)	0.0 mmHg Standard Deviation 6.4

SECONDARY outcome

Timeframe: baseline to15 minutes following device use

Measure change in systolic blood pressure average during baseline and 15 minutes following removal of the ITPR

Outcome measures

Measure	ITPR n=7 Participants Use of the ITPR for 120 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.
Change From Baseline in Systolic Blood Pressure (SBP)	9.4 mmHg Standard Deviation 18.5

SECONDARY outcome

Timeframe: baseline and 15 minutes after device activation

Population: PaCO2 values for comparison were not available for two subjects

PaCO2 will be collected during baseline and 15 minutes after device activation and change will be evaluated.

Outcome measures

Measure	ITPR n=5 Participants Use of the ITPR for 120 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.
Change From Baseline in PaCO2	-2.7 mmHg Standard Deviation 3.7

SECONDARY outcome

Timeframe: baseline to 15 minutes following device use

Measure change in diastolic blood pressure average during baseline and 15 minutes following removal of the ITPR

Outcome measures

Measure	ITPR n=7 Participants Use of the ITPR for 120 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.
Change From Baseline in Diastolic Blood Pressure (DBP)	4.5 mmHg Standard Deviation 6.3

SECONDARY outcome

Timeframe: baseline to 15 minutes following device use

Measure change in mean arterial pressure average during baseline and 15 minutes following removal of the ITPR

Outcome measures

Measure	ITPR n=7 Participants Use of the ITPR for 120 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.
Change From Baseline in Mean Arterial Pressure (MAP)	2.9 mmHg Standard Deviation 12.9

SECONDARY outcome

Timeframe: baseline to 15 minutes following device use

Measure change in heart rate average during baseline and 15 minutes following removal of the ITPR

Outcome measures

Measure	ITPR n=7 Participants Use of the ITPR for 120 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.
Change From Baseline in Heart Rate (HR)	0.3 beats/min Standard Deviation 6.0

SECONDARY outcome

Timeframe: baseline to 15 minutes following device use

Measure change in pulse pressure average during baseline and 15 minutes following removal of the ITPR

Outcome measures

Measure	ITPR n=7 Participants Use of the ITPR for 120 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.
Change From Baseline in Pulse Pressure (PP)	4.9 mmHg Standard Deviation 14.8

SECONDARY outcome

Timeframe: baseline to 15 minutes following device use

Measure change in EtCO2 average during baseline and 15 minutes following removal of the ITPR

Outcome measures

Measure	ITPR n=7 Participants Use of the ITPR for 120 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.
Change From Baseline in End-tidal Carbon Dioxide (EtCO2)	0.4 mmHg Standard Deviation 1.6

SECONDARY outcome

Timeframe: basseline to 15 minutes following device use

Measure change in SpO2 average during baseline and 15 minutes following removal of the ITPR

Outcome measures

Measure	ITPR n=7 Participants Use of the ITPR for 120 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.
Change From Baseline in Oxygen Saturation (SpO2)	-0.5 percentage of saturation Standard Deviation 1.5

Adverse Events

ITPR

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	ITPR n=9 participants at risk Use of the ITPR for 120 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	11.1% 1/9 • Number of events 1
Product Issues Device deficiency	11.1% 1/9 • Number of events 1
Vascular disorders Increased ICP	11.1% 1/9 • Number of events 1

Additional Information

Sr. Clinical Research Associate

Advanced Circulatory

Phone: 651.403.5606

Email: nburkhart@zoll.com

Results disclosure agreements

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