Recruiting NCT07537478
Respiration Measured Via End-tidal CO2 and Spirometry Study (RESPI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wearable Respiration mask - exercise, Wearable respiration Mask.
- Who it may be relevant to
- Registry conditions: Respiration Rate Detection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Respiration Measured Via End-tidal CO2 and Spirometry Study
Overview
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
- Device Wearable Respiration mask - exercise
Participants will be fitted for the respiration mask placed on their face to measure respiration data during rest and exercise. - Device Wearable respiration Mask
Participants will be fitted for the respiration mask placed on their face to measure respiration data during rest.
Primary outcome measures
- Respiratory rate detection - end tidal CO2 [Time frame: From enrollment through the end of the data collection visit, expected to take up to 3 hours.]
Secondary outcome measures (1)
- Respiratory rate detection - spirometry [Time frame: From enrollment through the data collection visit, up to 3 hours.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Boston Scientific Arden Hills — Saint Paul
Identifiers
NCT: NCT07537478 · C2193