Trial Outcomes & Findings for Novel Non-Invasive Monitoring Parameter in Healthy Volunteers (NCT NCT01294514)

Results Overview

Mean and standard deviations of respiration rates collected from healthy volunteers were compared between Covidien Respiration Rate Software, Transthoracic Impedance and Overscored End-Tidal Carbon Dioxide Waveforms. Each volunteer served as its own control.

Recruitment status

COMPLETED

Target enrollment

27 participants

Primary outcome timeframe

Participants were monitorerd on average of 30 minute period

Results posted on

2014-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Respiration Rate in Healthy Volunteers Healthy volunteer participants were monitored for 30 minute period to collect respiratory rate information from non-invasive sensors. Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide.
Overall Study STARTED	27
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Respiration Rate in Healthy Volunteers Healthy volunteer participants were monitored for 30 minute period to collect respiratory rate information from non-invasive sensors. Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide.
Overall Study Excluded due to Arrhythmia	1

Baseline Characteristics

Novel Non-Invasive Monitoring Parameter in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Volunteers n=27 Participants Healthy volunteers were studied
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	35 years STANDARD_DEVIATION 10 • n=99 Participants
Sex: Female, Male Female	15 Participants n=99 Participants
Sex: Female, Male Male	12 Participants n=99 Participants
Region of Enrollment United States	27 participants n=99 Participants

PRIMARY outcome

Timeframe: Participants were monitorerd on average of 30 minute period

Population: One participant was excluded from the analysis based on cardiac arrhythmia

Mean and standard deviations of respiration rates collected from healthy volunteers were compared between Covidien Respiration Rate Software, Transthoracic Impedance and Overscored End-Tidal Carbon Dioxide Waveforms. Each volunteer served as its own control.

Outcome measures

Outcome measures
Measure	Respiration Rate From Covidien Respiration Rate Software n=26 Participants Respiration Rate determined by novel plethysmographic analysis	Respiration Rate From Endtidal Carbon Dioxide n=26 Participants Respiration Rate determined by manual overscoring of capnography waveforms.	Respiration Rate From Transthoracic Impedance n=26 Participants Respiration Rate determined by Transthoracic Impedance
The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.	13.2 Breaths Per Minute (BrPM) Standard Deviation 3.0	13.8 Breaths Per Minute (BrPM) Standard Deviation 3.2	19.5 Breaths Per Minute (BrPM) Standard Deviation 9.4

SECONDARY outcome

Timeframe: Participants were monitored on average of 30 minute periods

Population: One participant was excluded from the data analysis based on cardiac arrhythmia

The data used for analysis consisted of multiple simultaneous measures of RR\_TTI, RR\_V1.0 and RR\_EtCO2 for each subject. Given N sets of simultaneous RR values for each of P patients, the simultaneous RR values were used to calculate a pair of RMSD values for each subject. The two RMSD values, RMSDRR\_V1.0\_vs\_EtCO2, and RMSDTTI\_vs\_EtCO2, quantify the mean absolute difference in simultaneous estimates of respiratory rate between RR\_V1.0 compared with RR\_EtCO2 and RR\_TTI compared with RR\_EtCO2, respectively for the subjects with 95% confidence of mean ± 3.38 BrPM. The Measure type is Number and represents the RMSD of Covidien Nellcor Respiration Rate Software

Outcome measures

Outcome measures
Measure	Respiration Rate From Covidien Respiration Rate Software n=26 Participants Respiration Rate determined by novel plethysmographic analysis	Respiration Rate From Endtidal Carbon Dioxide Respiration Rate determined by manual overscoring of capnography waveforms.	Respiration Rate From Transthoracic Impedance Respiration Rate determined by Transthoracic Impedance
The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.	0.84 Breaths Per Minute (BrPM)	—	—

POST_HOC outcome

Timeframe: Overall average

Population: One participant was excluded from the data analysis based on cardiac arrhythmia

The Covidien Nellcor Respiration Rate Software shall calculate respiration rate as mean error of +/- standard deviation.

Outcome measures

Outcome measures
Measure	Respiration Rate From Covidien Respiration Rate Software n=26 Participants Respiration Rate determined by novel plethysmographic analysis	Respiration Rate From Endtidal Carbon Dioxide Respiration Rate determined by manual overscoring of capnography waveforms.	Respiration Rate From Transthoracic Impedance Respiration Rate determined by Transthoracic Impedance
Calculate Covidien Respiration Rate Software Accuracy as Mean Error +/- Standard Deviation	0.37 Breaths Per Minute (BrPM) Standard Deviation 0.78	—	—

Adverse Events

Healthy Volunteers

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

Ulf Borg, Director of Clinical Affairs

Covidien

Phone: 303 305 2400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place