Respiratory Rate Accuracy - Healthy Adults

NCT03223870 | Completed FDA Device

• 1 other identifier: QATP3064
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Respiration Patterns

Outcome Measures

Primary Outcomes (1)

• Respiratory Rate Accuracy

  Values from the test device will be compared to the values from co-oximetry devices

  3 months

Study Arms (1)

Oximeters

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

Diagnostic Test: Diagnostic

Interventions

Diagnostic DIAGNOSTIC_TEST

Diagnostic

Oximeters

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A minimum of 30 subjects will be included in this study. The subject selection will be an approximately equal mix of males and females with varying skin tones. At a rate of 3-4 subjects per day, enrollment will take approximately 7-10 days to complete.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nonin Medical, Inc: lead

Study Sites (1)

Nonin Medical, Inc.

Plymouth, Minnesota, 55441, United States

Location

MeSH Terms

Interventions

Diagnosis

Study Officials

• Walter Holbein, Ph.D

  Nonin Medical, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 21, 2017
• Study Start: July 11, 2017
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: August 2, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)