Trial Outcomes & Findings for Vector Efficacy Cross-Over Pilot Study (NCT NCT04263532)

NCT ID: NCT04263532

Last Updated: 2025-05-09

Results Overview

Room air CO2 levels at the end of 4-6 weeks of therapy as determined by Arterial Blood Gas (PaCO2)

• Recruitment status: TERMINATED
• Target enrollment: 21 participants
• Primary outcome timeframe: At the end of the 4-to-6-week period
• Results posted on: 2025-05-09

Participant Flow

21 participants were consented and screened. 12 participants were screen failures, one of these participants was rescreened and determined to be eligible resulting in 10 participants being enrolled and randomized.

Participant milestones

Measure	NIV Current Users: Vector, Then Standard of Care NIV Experienced NIV participants assigned to the BiPAP A40 EFL device (Vector) for the first 4-6 week take home period followed by Standard of care for the second 4-6 week take home period.	NIV Current Users: Standard of Care NIV, Then Vector Experienced NIV participants assigned to the Standard of Care for the first 4-6 week take home period followed by BiPAP A40 EFL device (Vector) for the second 4-6 week take home period.
Overall Study STARTED	5	5
Overall Study COMPLETED	3	5
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	NIV Current Users: Vector, Then Standard of Care NIV Experienced NIV participants assigned to the BiPAP A40 EFL device (Vector) for the first 4-6 week take home period followed by Standard of care for the second 4-6 week take home period.	NIV Current Users: Standard of Care NIV, Then Vector Experienced NIV participants assigned to the Standard of Care for the first 4-6 week take home period followed by BiPAP A40 EFL device (Vector) for the second 4-6 week take home period.
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Vector Efficacy Cross-Over Pilot Study

Baseline characteristics by cohort

Measure	Randomized Participants n=10 Participants All participants that were enrolled and randomized.	Screen Fails n=11 Participants All participants that were screen failed.	Total n=21 Participants Total of all reporting groups
Age, Continuous	63.0 years STANDARD_DEVIATION 8.4 • n=5 Participants	70.1 years STANDARD_DEVIATION 4.7 • n=7 Participants	66.7 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	11 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: At the end of the 4-to-6-week period

Population: 10 participants were randomized, 2 participants received Standard of care for both arms, so they were excluded from analysis, 2 additional participants discontinued prior to completing both arms and they were excluded from the analysis. 1 participant did not contribute PaCO2 data. No NIV naive participants were enrolled.

Room air CO2 levels at the end of 4-6 weeks of therapy as determined by Arterial Blood Gas (PaCO2)

Outcome measures

Measure	Vector Device (NIV Current Users) n=5 Participants Experienced NIV participants assigned to the BiPAP A40 EFL device (Vector) for the 4-6 week take home period.	Standard of Care NIV (NIV Current Users) n=5 Participants Experienced NIV participants assigned to their Standard of care NIV prescription for the 4-6 week take home period. Participants will use a Vector Device in place of their current NIV device. The Vector therapy will not be enabled, and the device will be set according to their current standard of care NIV prescription.
Daytime PaCO2 (Arterial Blood Gas)	59.2 mmHG Standard Deviation 16.6	49.8 mmHG Standard Deviation 8.8

SECONDARY outcome

Timeframe: Up to 30 days of device use

Population: Processed data was only available N=3 participants. Average adherence was calculated among all days in the time period.

How many hours per night over 30 days that the participant uses the device.

Outcome measures

Measure	Vector Device (NIV Current Users) n=3 Participants Experienced NIV participants assigned to the BiPAP A40 EFL device (Vector) for the 4-6 week take home period.	Standard of Care NIV (NIV Current Users) n=3 Participants Experienced NIV participants assigned to their Standard of care NIV prescription for the 4-6 week take home period. Participants will use a Vector Device in place of their current NIV device. The Vector therapy will not be enabled, and the device will be set according to their current standard of care NIV prescription.
Average 30 Day Ventilator Usage Hours	7.58 hours Standard Deviation 4.52	7.40 hours Standard Deviation 3.38

SECONDARY outcome

Timeframe: Up to 30 days of device use

Population: 10 participants were randomized, 2 participants received Standard of care for both arms, and they were excluded from analysis, 2 additional participants discontinued prior to completing both arms and they were excluded from the analysis. The 6 participants answered comparative survey after completing both arms.

Comfort data from device satisfaction/preference questionnaire after 30 days of device use. The specific question analyzed was " Which ventilator pressure settings or therapy did you prefer?" Outcome was number of participants who selected each therapy as preferred.

Outcome measures

Measure	Vector Device (NIV Current Users) n=6 Participants Experienced NIV participants assigned to the BiPAP A40 EFL device (Vector) for the 4-6 week take home period.	Standard of Care NIV (NIV Current Users) n=6 Participants Experienced NIV participants assigned to their Standard of care NIV prescription for the 4-6 week take home period. Participants will use a Vector Device in place of their current NIV device. The Vector therapy will not be enabled, and the device will be set according to their current standard of care NIV prescription.
Patient Comfort and Therapy Preference Based Questionnaire Responses	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 30 days of device use

Population: Frequency of USADEs or SAEs when participant was using the assigned treatment. All SAEs which occurred were determined to be unrelated to the device. The term "incidence" in the protocol endpoint was imprecise. Frequency is the more appropriate term.

Incidence of Unanticipated Serious Adverse Device Effects (USADEs) and Serious Adverse Events (SAEs) for the Vector vs. the control group.

Outcome measures

Measure	Vector Device (NIV Current Users) n=10 Participants Experienced NIV participants assigned to the BiPAP A40 EFL device (Vector) for the 4-6 week take home period.	Standard of Care NIV (NIV Current Users) n=10 Participants Experienced NIV participants assigned to their Standard of care NIV prescription for the 4-6 week take home period. Participants will use a Vector Device in place of their current NIV device. The Vector therapy will not be enabled, and the device will be set according to their current standard of care NIV prescription.
Unanticipated Serious Adverse Device Effects (USADEs) and Serious Adverse Events (SAEs) Assessment	3 Participants	0 Participants

Adverse Events

NIV Current Users: Vector

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

NIV Current Users: Standard of Care NIV

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	NIV Current Users: Vector n=10 participants at risk Experienced NIV participants assigned to the BiPAP A40 EFL device (Vector) for a 4-6 week take home period.	NIV Current Users: Standard of Care NIV n=10 participants at risk Experienced NIV participants assigned to the Standard of Care for a 4-6 week take home period.
Respiratory, thoracic and mediastinal disorders COPD exacerbation	10.0% 1/10 • Number of events 1 • Approximately 15 weeks.	0.00% 0/10 • Approximately 15 weeks.
Respiratory, thoracic and mediastinal disorders Shortness of Breath and left sided chest discomfort	10.0% 1/10 • Number of events 1 • Approximately 15 weeks.	0.00% 0/10 • Approximately 15 weeks.
Blood and lymphatic system disorders Hypervolemia	10.0% 1/10 • Number of events 1 • Approximately 15 weeks.	0.00% 0/10 • Approximately 15 weeks.

Other adverse events

Measure	NIV Current Users: Vector n=10 participants at risk Experienced NIV participants assigned to the BiPAP A40 EFL device (Vector) for a 4-6 week take home period.	NIV Current Users: Standard of Care NIV n=10 participants at risk Experienced NIV participants assigned to the Standard of Care for a 4-6 week take home period.
Ear and labyrinth disorders Ear pain	0.00% 0/10 • Approximately 15 weeks.	10.0% 1/10 • Number of events 1 • Approximately 15 weeks.
Respiratory, thoracic and mediastinal disorders Abnormal Blood gas level	20.0% 2/10 • Number of events 2 • Approximately 15 weeks.	0.00% 0/10 • Approximately 15 weeks.
Injury, poisoning and procedural complications Motor Vehicle Accident	0.00% 0/10 • Approximately 15 weeks.	10.0% 1/10 • Number of events 1 • Approximately 15 weeks.

Additional Information

Chuck Cain

Philips

Phone: 412-657-1814

Email: chuck.cain@philips.com

Results disclosure agreements

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