Respiration Rate Detection
Conditions
Keywords
end tidal co2, spirometry
Brief summary
To collect respiration data via end-tidal CO2 and spirometry and compare respiration rates measured via the two methods.
Detailed description
This is a non-randomized, data collection study that will enroll up to 50 participants. There will be one study visit per participant and no follow up period.
Interventions
DEVICEWearable Respiration mask - exercise
Participants will be fitted for the respiration mask placed on their face to measure respiration data during rest and exercise.
DEVICEWearable respiration Mask
Participants will be fitted for the respiration mask placed on their face to measure respiration data during rest.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to provide informed consent * Age 18 or above * Full time or part time BSC employee * Willing and able to participate in the required testing
Exclusion criteria
* Currently enrolled in another clinical trial that might interfere with data collection or placement of the study system * Subject is pregnant as indicated by subject report * Known allergy or sensitivity to materials used in the study (Neoprene, Nylon) * Any past or current medical event that could represent a risk for the subject to perform the study required activities in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate detection - end tidal CO2 | From enrollment through the end of the data collection visit, expected to take up to 3 hours. | End-Tidal CO2 will be measured as a fractional concentration (volume percent of CO₂ in exhaled gas). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate detection - spirometry | From enrollment through the data collection visit, up to 3 hours. | Spirometry will be measured as Forced Vital Capacity (FVC). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKevin Chu, PhD
Boston Scientific Corporation
Outcome results
None listed