NCT03223870

Respiratory Rate Accuracy - Healthy Adults

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Nonin Medical, Inc · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the Fingertip Respiratory Rate algorithm performance of the Nonin Medical X-100SP pulse oximetry systems with the 8300AA sensors and Onyx 3 fingertip oximeter. There is no treatment or interventions being performed.

Detailed description

1. Start data collection system(s) and allow them to run 15 minutes prior to study start of each subject. 2. Confirm that the subject meets inclusion/exclusion criteria and has signed the current IRB- approved Informed Consent Form 3. Collect Demographic and Anthropometric Data from the subject. 4. Place Pulse Oximetry Sensors 5. Place nasal cannula for capnography recordings 6. A summary of Respiratory rate protocol. 1. Stage 1: Subject will rest quietly and breathe at a normal comfortable rate for 40 minutes. The start and stop times will be marked on the data collection system. 2. Stage 2: Immediately after Stage 1 is complete, the subject will start the 25 minute paced breathing protocol which will ramp from 5-45 BPM. A computer program will be used to guide the subject through the stage 2 paced breathing. The start and stop times will be marked on the data collection system.

Conditions

• Normal Respiration Patterns

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnostic	Diagnostic

Timeline

• Start date: 2017-07-11
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2017-07-21
• Last updated: 2017-08-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study