Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Respiratory Rate Accuracy - Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 13, 2017
First Posted Date July 21, 2017
Last Update Posted Date August 2, 2017
Actual Study Start Date July 11, 2017
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2017)
Respiratory Rate Accuracy [ Time Frame: 3 months ]
Values from the test device will be compared to the values from co-oximetry devices
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03223870 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Respiratory Rate Accuracy - Healthy Adults
Official Title Respiratory Rate Accuracy - Healthy Adults
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Normal Respiration Patterns
Intervention Diagnostic Test: Diagnostic
Diagnostic
Study Groups/Cohorts Oximeters
Comparison of respiratory rates with other devices in normal subjects as observational with other pulse oximeters. No treatment of interventions will be performed.
Intervention: Diagnostic Test: Diagnostic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 1, 2017)
30
Original Estimated Enrollment
 (submitted: July 14, 2017)
60
Actual Study Completion Date July 31, 2017
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03223870
Other Study ID Numbers QATP3064
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Nonin Medical, Inc
Study Sponsor Nonin Medical, Inc
Collaborators Not Provided
Investigators
Principal Investigator: Walter Holbein, Ph.D Nonin Medical, Inc
PRS Account Nonin Medical, Inc
Verification Date August 2017