Respiratory Rate Accuracy - Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: Normal Respiration Patterns
• Intervention / Treatment: Diagnostic test: Diagnostic

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Nonin Medical, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Diagnostic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Rate Accuracy	Values from the test device will be compared to the values from co-oximetry devices	3 months

Collaborators and Investigators

• Sponsor: Nonin Medical, Inc
• Investigators: Principal Investigator: Walter Holbein, Ph.D, Nonin Medical, Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 14, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: QATP3064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes