Trial Outcomes & Findings for Novel Non-Invasive Monitoring Parameter in a Hospital Setting (NCT NCT01306201)

Results Overview

Mean and standard deviations of respiration rates collected from patients in the hospital settings were compared between Covidien Respiration Rate Software, Transthoracic Impedance and End-Tidal Carbon Dioxide Waveforms. Each patient served as its own control.

Recruitment status

COMPLETED

Target enrollment

63 participants

Primary outcome timeframe

Participants were monitored for average of 30 minutes

Results posted on

2014-08-07

Participant Flow

Recruitment dates were February 10, 2011- to March 4th,2011

Participant milestones

Participant milestones
Measure	Respiration Rate in GCF Patients In-patients from the hospital general care floor, who choose to participate in the study. Participants were monitored for 30 minute periods to collect respiratory rate information from non-invasive sensors.
Overall Study STARTED	63
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Respiration Rate in GCF Patients In-patients from the hospital general care floor, who choose to participate in the study. Participants were monitored for 30 minute periods to collect respiratory rate information from non-invasive sensors.
Overall Study Arrhythmia	4
Overall Study Files could not be processed	3
Overall Study Files unreadable	3

Baseline Characteristics

Novel Non-Invasive Monitoring Parameter in a Hospital Setting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	In-patient Volunteers n=63 Participants In-patients from the hospital who choose to participate in the study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	47 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants

PRIMARY outcome

Timeframe: Participants were monitored for average of 30 minutes

Population: 10 participants were excluded from data analysis due to following reasons: unreadable files,arrhythmia,electronic data files coud not be processed

Mean and standard deviations of respiration rates collected from patients in the hospital settings were compared between Covidien Respiration Rate Software, Transthoracic Impedance and End-Tidal Carbon Dioxide Waveforms. Each patient served as its own control.

Outcome measures

Outcome measures
Measure	Respiration Rate From Covidien Respiration Rate Software n=53 Participants Respiration rate determined by novel plethysmographic analysis	Respiration Rate From Endtidal Carbon Dioxide Waveform n=53 Participants Respiration rate determined by manual overscoring of capnography waveforms	Respiration Rate From Transthoracic Impedance n=53 Participants Respiration Rate derived from 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.	15.4 BrPM (Breaths Per Minute) Standard Deviation 4.0	16.0 BrPM (Breaths Per Minute) Standard Deviation 4.6	16.8 BrPM (Breaths Per Minute) Standard Deviation 4.8

SECONDARY outcome

Timeframe: Participants were monitored on average for 30 minutes

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=53 Participants Respiration rate determined by novel plethysmographic analysis	Respiration Rate From Endtidal Carbon Dioxide Waveform Respiration rate determined by manual overscoring of capnography waveforms	Respiration Rate From Transthoracic Impedance Respiration Rate derived from 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.	1.60 Breaths Per Minute (BrPM)	—	—

POST_HOC outcome

Timeframe: Overall average

Outcome measures

Outcome measures
Measure	Respiration Rate From Covidien Respiration Rate Software n=53 Participants Respiration rate determined by novel plethysmographic analysis	Respiration Rate From Endtidal Carbon Dioxide Waveform Respiration rate determined by manual overscoring of capnography waveforms	Respiration Rate From Transthoracic Impedance Respiration Rate derived from Transthoracic Impedance
Calculate Covidien Respiration Rate Software Accuracy as Mean Error +/- Standard Deviation.	0.07 Breaths Per Minute (BrPM) Standard Deviation 1.98	—	—

Adverse Events

In-patient 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