Respiratory Rate Accuracy - Healthy Adults

Completed

• Conditions: Normal Respiration Patterns
• Interventions: Diagnostic Test: Diagnostic

• Registration Number: NCT03223870
• Lead Sponsor: Nonin Medical, Inc

Brief 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.

Study Timeline

• Study Start: 2017-07-11
• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-14
• Study First Posted: 2017-07-21
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-01
• Last Update Posted: 2017-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• The subject is male or female
• The subject is of any racial or ethnic group
• The subject is > 30 kg (>66 pounds) in weight (based on measurement)
• The subject has at least one finger with a height of 0.3 - 1.0 inch (7.6 -25.4 mm) (based on measurement)
• The subject is between 18 years and 50 years of age (self-reported)
• The subject has given written informed consent to participate in the study
• The subject is both willing and able to comply with study procedures.

Exclusion Criteria

• The subject has a BMI greater than 30 (based on weight and height)
• The subject has a history of atrial fibrillation (self-reported)
• The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as >3 per 30 seconds (self-reported)
• The subject has an implanted pacemaker (self-reported)
• The subject has had any relevant injury at the sensor location site (self-reported)
• The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination)
• The subject has a known respiratory condition (self-reported)
• The subject has a known heart or cardiovascular condition (self-reported)
• The subject is currently pregnant (self-reported)
• The subject is actively trying to get pregnant (self-reported)
• The subject is unwilling or unable to provide written informed consent to participate in the study
• The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oximeters	Diagnostic	Comparison of respiratory rates with other devices in normal subjects as observational with other pulse oximeters. No treatment of interventions will be performed.

Primary Outcome Measures

Name	Time	Method
Respiratory Rate Accuracy	3 months	Values from the test device will be compared to the values from co-oximetry devices

Trial Locations

Locations (1)

Nonin Medical, Inc.; 🇺🇸 Plymouth, Minnesota, United States