Trial Outcomes & Findings for Rainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study (NCT NCT03482505)
NCT ID: NCT03482505
Last Updated: 2021-11-15
Results Overview
Acoustic respiration rate (RRa) as determined by the INVSENSOR00004 will be compared to measurements of actual respiration rates as determined by manual annotation of recorded respiration waveform (RRref) data. Evaluation of the RRa measurements will be reported as bias between the RRa and the RRref.
TERMINATED
NA
10 participants
One study visit lasting up to 60 minutes.
2021-11-15
Participant Flow
Participant milestones
| Measure |
INVSENSOR00004
All enrolled subjects will receive the INVSENSOR00004 sensor. The INVSENSOR00004 rainbow acoustic monitoring (RAM) acoustic respiration sensor is designed to noninvasively convert acoustical airflow patterns into respiratory rate (RRa).
INVSENSOR00004: The INVSENSOR00004 will be placed on the subject's neck or chest to provide acoustic respiration rate.
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|---|---|
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Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
INVSENSOR00004
n=10 Participants
All enrolled subjects will receive the INVSENSOR00004 sensor. The INVSENSOR00004 rainbow acoustic monitoring (RAM) acoustic respiration sensor is designed to noninvasively convert acoustical airflow patterns into respiratory rate (RRa).
INVSENSOR00004: The INVSENSOR00004 will be placed on the subject's neck or chest to provide acoustic respiration rate.
|
|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: One study visit lasting up to 60 minutes.Population: Sufficient number of cases to meet sample size criteria for assessing outcomes was not achieved. The protocol required a minimum of 18 subjects with valid breaths to calculate the bias, precision, and ARMS of the study. This study was not able to meet this target and therefore the bias, precision, and ARMS could not be calculated (primary outcome measure).
Acoustic respiration rate (RRa) as determined by the INVSENSOR00004 will be compared to measurements of actual respiration rates as determined by manual annotation of recorded respiration waveform (RRref) data. Evaluation of the RRa measurements will be reported as bias between the RRa and the RRref.
Outcome measures
Outcome data not reported
Adverse Events
INVSENSOR00004
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60