Trial Outcomes & Findings for Respiration Rate V2.0 in a Hospital Setting (NCT NCT01837537)

NCT ID: NCT01837537

Last Updated: 2017-07-17

Results Overview

The software calculates respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography).

• Recruitment status: COMPLETED
• Target enrollment: 90 participants
• Primary outcome timeframe: up to 40 minutes of continuous monitoring
• Results posted on: 2017-07-17

Participant Flow

Participant milestones

Measure	no Treatment no treatment, prospective observational
Overall Study STARTED	90
Overall Study COMPLETED	90
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Respiration Rate V2.0 in a Hospital Setting

Baseline characteristics by cohort

Measure	no Treatment n=90 Participants no treatment, prospective observational
Age, Continuous	54.2 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 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	12 Participants n=5 Participants
Race (NIH/OMB) White	76 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	90 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 40 minutes of continuous monitoring

Population: 90 subjects were enrolled. Out of the 90 enrolled 75 yielded valid data. The remaining 15 subjects did not meet the predetermined data criteria (such as reference was too noisy, timing of observations could not be matched, etc.)

The software calculates respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography).

Outcome measures

Measure	no Treatment n=75 Participants no treatment, prospective observational
Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor	-0.82 BrPM (breaths per minute) Standard Deviation 2.19

SECONDARY outcome

Timeframe: up to 40 minutes of continuous monitoring

Population: 90 subjects were enrolled. Out of the 90 enrolled 75 yielded valid data. The remaining 15 subjects did not meet the predetermined data criteria (such as reference was too noisy, timing of observations could not be matched, etc.)

The software calculates respiration rate values via the Max-N Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography). The error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the Max-N sensor minus the Respiration Rate calculated from capnography.

Outcome measures

Measure	no Treatment n=75 Participants no treatment, prospective observational
Mean Error (ME) +/- 1 Breath Per Minute, Max-N Sensor	-0.16 BrPM Standard Deviation 2.85

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