Respiration Measured Via End-tidal CO2 and Spirometry Study (RESPI)

Boston Scientific Corporation50 enrolled

Overview

To collect respiration data via end-tidal CO2 and spirometry and compare respiration rates measured via the two methods.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Respiration Rate Detection

Interventions

Wearable Respiration mask - exerciseDEVICE

Participants will be fitted for the respiration mask placed on their face to measure respiration data during rest and exercise.

Wearable respiration MaskDEVICE

Participants will be fitted for the respiration mask placed on their face to measure respiration data during rest.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Boston Scientific Arden Hills

Saint Paul, Minnesota, United States

Outcomes

Primary Outcomes

Respiratory rate detection - end tidal CO2

End-Tidal CO2 will be measured as a fractional concentration (volume percent of CO₂ in exhaled gas).

Time frame: From enrollment through the end of the data collection visit, expected to take up to 3 hours.

Secondary Outcomes

Respiratory rate detection - spirometry

Spirometry will be measured as Forced Vital Capacity (FVC).

Time frame: From enrollment through the data collection visit, up to 3 hours.

Data from ClinicalTrials.gov

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