Trial Outcomes & Findings for Respiration Rate V2.0 in Healthy Volunteers (NCT NCT01804062)

NCT ID: NCT01804062

Last Updated: 2015-08-10

Results Overview

The software shall calculate respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference.

• Recruitment status: COMPLETED
• Target enrollment: 30 participants
• Primary outcome timeframe: up to 40 minutes of continous monitoring
• Results posted on: 2015-08-10

Participant Flow

Participant milestones

Measure	no Treatment no treatment, prospective observational
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Respiration Rate V2.0 in Healthy Volunteers

Baseline characteristics by cohort

Measure	no Treatment n=30 Participants no treatment, prospective observational
Age, Continuous	32.9 years STANDARD_DEVIATION 6.97 • n=93 Participants
Sex: Female, Male Female	13 Participants n=93 Participants
Sex: Female, Male Male	17 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	27 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	30 participants n=93 Participants

PRIMARY outcome

Timeframe: up to 40 minutes of continous monitoring

The software shall calculate respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference.

Outcome measures

Measure	no Treatment n=30 Participants no treatment, prospective observational
Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor	-0.05 BrPM Standard Deviation 1.04

SECONDARY outcome

Timeframe: up to 40 minutes of continuous monitoring

The software shall calculate respiration rate values via Max-N with a mean error of +/- 1 breath per minute relative to a capnography based reference.

Outcome measures

Measure	no Treatment n=30 Participants no treatment, prospective observational
ME +/- 1 Breath Per Minute, Max-N Sensor	-0.03 BrPM Standard Deviation 1.05

Adverse Events

no Treatment

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

Michael Luna-Victoria

Medtronic

Phone: 303 305 2463

Email: michael.luna-victoria@medtronic.com

Results disclosure agreements

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