Clinical trial NCT03223870: Respiratory Rate Accuracy - Healthy Adults
Official title: Respiratory Rate Accuracy - Healthy Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Respiration Patterns
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
First posted: 2017-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Respiratory Rate Accuracy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Plymouth
country: United States
facility: Nonin Medical, Inc.
state: Minnesota
Study officials:
affiliation: Nonin Medical, Inc
name: Walter Holbein, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: