Respiratory Rate Accuracy - Healthy Adults

NCT ID: NCT03223870

Last Updated: 2017-08-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-11
• Study Completion Date: 2017-07-31

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.

Conditions

Normal Respiration Patterns

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: DIAGNOSTIC_TEST

Diagnostic

Interventions

Diagnostic

Diagnostic

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nonin Medical, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter Holbein, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Nonin Medical, Inc

Locations

Nonin Medical, Inc.

Plymouth, Minnesota, United States

Countries

United States

Other Identifiers

QATP3064

Identifier Type: -

Identifier Source: org_study_id