Trial Outcomes & Findings for Evaluating the Non-Inferiority of Airmod to Capnostream™35 (NCT NCT05263791)

Last Updated: 2024-11-19

Results Overview

The mean difference is based on the comparative pair (reference: mancRR - device under test: airRR) (unit: BPM) The measurement of airRR (airmod recorded breathing rate per minute: BPM ) (minimal: 4 BPM, maximal: 35BPM) The measurement of mancRR (manual scored capnography breathing rate per minute: BPM) (minimal : 0 BPM, maximal 39BPM)

Recruitment status

COMPLETED

Study phase

Target enrollment

284 participants

Primary outcome timeframe

up to 4 hours

Results posted on

2024-11-19

Participant Flow

The candidate was invited during their pre-anesthesia appointment and provided with an informed consent form, which explained the details, benefits, and risks of participating in the study. Research staff simultaneously reviewed the candidate's eligibility. The candidate was given at least one day to review and sign the informed consent form before proceeding with the procedures and being formally enrolled in the study.

Participant milestones

Participant milestones
Measure	Airmod The experimental device are installed in the same patient as the reference device to compare the non-inferiority of the respiratory rate measurement. Both of the respiratory rate monitor (including experimental and reference device) are installed on the enrolled patients. The practitioners can clearly read the result of both devices. experimenta device: Aimed reference device: "Medtronic Capnostream™35 Portable Respiratory Monitor
Overall Study STARTED	284
Overall Study COMPLETED	255
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Airmod n=255 Participants The experimental device are installed in the same patient as the reference device to compare the non-inferiority of the respiratory rate measurement. Airmod: Both of the respiratory rate monitor (including experimental and reference device) are installed on the enrolled patients. The practitioners can clearly read the result of both devices.
Age, Continuous	50.26 years STANDARD_DEVIATION 13.22 • n=255 Participants
Sex: Female, Male Female	183 Participants n=255 Participants
Sex: Female, Male Male	72 Participants n=255 Participants
Region of Enrollment Taiwan	255 participants n=255 Participants
Body Mass Index (BMI)	24.3 kg/m^2 STANDARD_DEVIATION 4.42 • n=255 Participants
Neck circumference	35.74 cm STANDARD_DEVIATION 4.51 • n=255 Participants
Height	161.81 cm STANDARD_DEVIATION 7.22 • n=255 Participants
Weight	63.82 kg STANDARD_DEVIATION 13.44 • n=255 Participants
Charlson Comorbidity Scale 0	119 Participants n=255 Participants
Charlson Comorbidity Scale 1	59 Participants n=255 Participants
Charlson Comorbidity Scale 2	36 Participants n=255 Participants
Charlson Comorbidity Scale 3	18 Participants n=255 Participants
Charlson Comorbidity Scale 4	11 Participants n=255 Participants
Charlson Comorbidity Scale 5	7 Participants n=255 Participants
Charlson Comorbidity Scale 6	2 Participants n=255 Participants
Charlson Comorbidity Scale 7	1 Participants n=255 Participants
Charlson Comorbidity Scale 8	1 Participants n=255 Participants
Charlson Comorbidity Scale 9	1 Participants n=255 Participants
American Society of Anesthesiologists' Physical Status Classification 1	17 Participants n=255 Participants
American Society of Anesthesiologists' Physical Status Classification 2	207 Participants n=255 Participants
American Society of Anesthesiologists' Physical Status Classification 3	31 Participants n=255 Participants

PRIMARY outcome

Timeframe: up to 4 hours

Outcome measures

Outcome measures
Measure	Airmod n=6920 minute The experimental device are installed in the same patient as the reference device to compare the non-inferiority of the respiratory rate measurement. Both of the respiratory rate monitor (including experimental and reference device) are installed on the enrolled patients. The practitioners can clearly read the result of both devices. experimenta device: Aimed reference device: "Medtronic Capnostream™35 Portable Respiratory Monitor
Test of the Difference Between airRR and mancRR mancRR - airRR	0.422 breaths per minute Interval 0.3522 to 0.4909
Test of the Difference Between airRR and mancRR airRR	14.362 breaths per minute Interval 14.2598 to 14.4644
Test of the Difference Between airRR and mancRR mancRR	14.784 breaths per minute Interval 14.6723 to 14.895

SECONDARY outcome

Timeframe: up to 4 hours

The mean difference is based on the comparative pair (reference: acoRR - device under test: airRR) (unit: BPM) The measurement of airRR (airmod recorded breathing rate per minute: BPM ) (minimal: 4 BPM, maximal: 35BPM) The measurement of acoRR (manual scored auscultation sound breathing rate per minute: BPM) (minimal : 0 BPM, maximal 60BPM)

Outcome measures

Outcome measures
Measure	Airmod n=160 minute The experimental device are installed in the same patient as the reference device to compare the non-inferiority of the respiratory rate measurement. Both of the respiratory rate monitor (including experimental and reference device) are installed on the enrolled patients. The practitioners can clearly read the result of both devices. experimenta device: Aimed reference device: "Medtronic Capnostream™35 Portable Respiratory Monitor
Analysis to Assess the Accuracy of Respiratory Rate Measurement by Airmod in Comparison With Manual-scored Auscultation Sound During the Less Sensitive Period of Capnography on Capnostream™35 airRR	14.25 breaths per minute Standard Deviation 4.15
Analysis to Assess the Accuracy of Respiratory Rate Measurement by Airmod in Comparison With Manual-scored Auscultation Sound During the Less Sensitive Period of Capnography on Capnostream™35 acoRR	13.14 breaths per minute Standard Deviation 5.31
Analysis to Assess the Accuracy of Respiratory Rate Measurement by Airmod in Comparison With Manual-scored Auscultation Sound During the Less Sensitive Period of Capnography on Capnostream™35 airRR-acoRR	1.11 breaths per minute Standard Deviation 3.71

SECONDARY outcome

Timeframe: up to 4 hours

The Bland-Altman plot and limits of agreement compare the following respiratory rates, all measured in BPM: airRR (Airmod recorded respiratory rate), capRR (capnography recorded respiratory rate), and acoRR (manually scored auscultation respiratory rate) against mancRR (manually scored capnography respiratory rate).

Outcome measures

Outcome measures
Measure	Airmod n=6920 breaths per minute The experimental device are installed in the same patient as the reference device to compare the non-inferiority of the respiratory rate measurement. Both of the respiratory rate monitor (including experimental and reference device) are installed on the enrolled patients. The practitioners can clearly read the result of both devices. experimenta device: Aimed reference device: "Medtronic Capnostream™35 Portable Respiratory Monitor
Analysis to Measure the Agreement Between AirRR and ManCRR (Limits of Agreement and Bland-Altman Plots) manCRR - airRR	0.42155 breaths per minute Interval 0.3522 to 0.4909
Analysis to Measure the Agreement Between AirRR and ManCRR (Limits of Agreement and Bland-Altman Plots) manCRR - capRR	-0.0009 breaths per minute Interval -0.0626 to 0.0608
Analysis to Measure the Agreement Between AirRR and ManCRR (Limits of Agreement and Bland-Altman Plots) manCRR - acoRR	0.31701 breaths per minute Interval 0.2506 to 0.3835

SECONDARY outcome

Timeframe: up to 4 hours

Population: In this analysis, we investigated the response time of the first breath detection followed by the administration of a jaw thrust maneuver during the apnea period. As part of the study's third secondary objective, we aimed to compare the response time between the Airmod device and Capnography.

We examined the response time for detecting the first breath after administering a jaw thrust maneuver during an apnea period. The results included the latency of the Airmod breathing response (measured in seconds), the latency of capnography (measured in seconds), and the difference in latency between Airmod and capnography (measured in seconds).

Outcome measures

Outcome measures
Measure	Airmod n=130 event The experimental device are installed in the same patient as the reference device to compare the non-inferiority of the respiratory rate measurement. Both of the respiratory rate monitor (including experimental and reference device) are installed on the enrolled patients. The practitioners can clearly read the result of both devices. experimenta device: Aimed reference device: "Medtronic Capnostream™35 Portable Respiratory Monitor
Analysis to Evaluate the Response Time of the First Breath Detection Followed by Administration of Jaw Thrust During the Apnea Period Airmod	12.61 sec Standard Deviation 14.03
Analysis to Evaluate the Response Time of the First Breath Detection Followed by Administration of Jaw Thrust During the Apnea Period Capnography	28.93 sec Standard Deviation 20.62
Analysis to Evaluate the Response Time of the First Breath Detection Followed by Administration of Jaw Thrust During the Apnea Period Airmod-Capnography	-16.32 sec Standard Deviation 21.83

SECONDARY outcome

Timeframe: up to 4 hours

Outcome measures

Outcome measures
Measure	Airmod n=6920 breaths per minute The experimental device are installed in the same patient as the reference device to compare the non-inferiority of the respiratory rate measurement. Both of the respiratory rate monitor (including experimental and reference device) are installed on the enrolled patients. The practitioners can clearly read the result of both devices. experimenta device: Aimed reference device: "Medtronic Capnostream™35 Portable Respiratory Monitor
Analysis to Compare the Influence of Subjects to Variated Breath Rates on Respiratory Rate Monitoring in Bpm as Measured by Airmod, Manual-scored and Capnostream™35 mancRR - airRR	0.422 breaths per minute Interval 0.3522 to 0.4909
Analysis to Compare the Influence of Subjects to Variated Breath Rates on Respiratory Rate Monitoring in Bpm as Measured by Airmod, Manual-scored and Capnostream™35 airRR	14.362 breaths per minute Interval 14.2598 to 14.4644
Analysis to Compare the Influence of Subjects to Variated Breath Rates on Respiratory Rate Monitoring in Bpm as Measured by Airmod, Manual-scored and Capnostream™35 mancRR	14.784 breaths per minute Interval 14.6723 to 14.895

SECONDARY outcome

Timeframe: In the study , All participants spend less than 30 min writing thesis questionnaire.

Population: airmod operator

Questionnaire response from research staff, each question score 0 or 1 by candidate, the result stands for successful numbers over all candidates in specific question.

Outcome measures

Outcome measures
Measure	Airmod n=8 Participants The experimental device are installed in the same patient as the reference device to compare the non-inferiority of the respiratory rate measurement. Both of the respiratory rate monitor (including experimental and reference device) are installed on the enrolled patients. The practitioners can clearly read the result of both devices. experimenta device: Aimed reference device: "Medtronic Capnostream™35 Portable Respiratory Monitor
Safety and Usability of Airmod. Were you able to complete this study? (Yes:1, No:0)	8 participants
Safety and Usability of Airmod. Were you able to turn on Airmod APP? (Yes:1, No:0)	8 participants
Safety and Usability of Airmod. Were you able to connect Airmod APP to AS-101? (Yes:1, No:0)	7 participants
Safety and Usability of Airmod. Were you able to record the breath sound ? (Yes:1, No:0)	8 participants
Safety and Usability of Airmod. Were you able to key in patient's info? (Yes:1, No:0)	7 participants
Safety and Usability of Airmod. Were you able to adjust the sound playback mode? (Yes:1, No:0)	8 participants
Safety and Usability of Airmod. Were you able to stop the breath sound recording ? (Yes:1, No:0)	8 participants
Safety and Usability of Airmod. Were you able to adjust settings? (Yes:1, No:0)	8 participants
Safety and Usability of Airmod. Were you able to review patient's breath sound recording? (Yes:1, No:0)	8 participants
Safety and Usability of Airmod. Overall, were you able to use Airmod APP? (Yes:1, No:0)	8 participants

Adverse Events

Airmod

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

Chien-Chung Huang

MacKay Memorial Hospital

Phone: 02-25433535

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place