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
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|