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Respiratory Rate Accuracy - Healthy Adults

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ClinicalTrials.gov Identifier: NCT03223870
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Normal Respiration Patterns 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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Respiratory Rate Accuracy - Healthy Adults
Actual Study Start Date : July 11, 2017
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

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




Primary Outcome Measures :
  1. Respiratory Rate Accuracy [ Time Frame: 3 months ]
    Values from the test device will be compared to the values from co-oximetry devices



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223870


Locations
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United States, Minnesota
Nonin Medical, Inc.
Plymouth, Minnesota, United States, 55441
Sponsors and Collaborators
Nonin Medical, Inc
Investigators
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Principal Investigator: Walter Holbein, Ph.D Nonin Medical, Inc

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Responsible Party: Nonin Medical, Inc
ClinicalTrials.gov Identifier: NCT03223870     History of Changes
Other Study ID Numbers: QATP3064
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes