Trial Outcomes & Findings for Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators (NCT NCT00817804)

NCT ID: NCT00817804

Last Updated: 2009-08-19

Results Overview

Comfort on visual analog scale 0 - 100, 0 is best

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2009-08-19

Participant Flow

Hospitalized adult patients enrolled between Jan 17 and Mar 3, 2009.

Excluded if did not meet inclusion or did meet exclusion criteria.

Participant milestones

Measure	V60 First Experimental Study device (used as the experimental device) first in the cross-over study	Conventional First Experimental Study device (used as the experimental device) second in the cross-over study
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators

Baseline characteristics by cohort

Measure	V60 First n=1 Participants Experimental Study device (used as the experimental device) first in the cross-over study	Conventional First n=2 Participants Experimental Study device (used as the experimental device) second in the cross-over study	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	16.0 years STANDARD_DEVIATION 0 • n=5 Participants	11.5 years STANDARD_DEVIATION 4.9 • n=7 Participants	13.0 years STANDARD_DEVIATION 4.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Canada	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes

Population: Analysis was per protocol

Comfort on visual analog scale 0 - 100, 0 is best

Outcome measures

Measure	V60 First n=1 Participants Experimental Study device (used as the experimental device) first in the cross-over study	Conventional First n=2 Participants Experimental Study device (used as the experimental device) second in the cross-over study
Breathing Comfort V60	10 visual analog scale Standard Error 0	40 visual analog scale Standard Error 14.1
Breathing Comfort Conventional	33.3 visual analog scale Standard Error 0	45 visual analog scale Standard Error 7.1

SECONDARY outcome

Timeframe: 30 minutes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 minutes

Breathing rate in breaths per minute

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 minutes

Liters per minute that the patient breathes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 minutes

Beats per minute that the patient's heart is beating

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 minutes

Systolic and diastolic blood pressure

Outcome measures

Outcome data not reported

Adverse Events

V60 First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Adam Seiver

Respironics California

Phone: 760-703-6993

Email: adam.seiver@philips.com

Results disclosure agreements

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

Restriction type: LTE60