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
|Condition or disease||Intervention/treatment|
|Normal Respiration Patterns||Diagnostic Test: Diagnostic|
- Start data collection system(s) and allow them to run 15 minutes prior to study start of each subject.
- Confirm that the subject meets inclusion/exclusion criteria and has signed the current IRB- approved Informed Consent Form
- Collect Demographic and Anthropometric Data from the subject.
- Place Pulse Oximetry Sensors
- Place nasal cannula for capnography recordings
A summary of Respiratory rate protocol.
- 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.
- 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|
|Actual Enrollment :||30 participants|
|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|
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
- Respiratory Rate Accuracy [ Time Frame: 3 months ]Values from the test device will be compared to the values from co-oximetry devices
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
|United States, Minnesota|
|Nonin Medical, Inc.|
|Plymouth, Minnesota, United States, 55441|
|Principal Investigator:||Walter Holbein, Ph.D||Nonin Medical, Inc|