Healthy Subjects Clinical Trial
Official title:
Respiration Rate Parameter Studies in Healthy Volunteers Using a Bedside Respiratory Patient Monitoring System With the Multi-Functional Patient Monitoring PCBA-1
Verified date | December 2013 |
Source | Medtronic - MITG |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
To assess performance of resp rate parameter in a monitoring system PCBA-1
Status | Completed |
Enrollment | 27 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. Male or female subjects ages 18 or older. 2. Subject is willing and able to provide written consent. Exclusion Criteria: 1. Subject has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors. 2. Subjects with abnormalities that may prevent proper application of the device. 3. Subjects with significant Arrhythmia, as determined by subject self-report during screening and I/E criteria assessment at study start. (Three events of irregularities in radial pulse within thirty seconds). 4. Women who are pregnant or lactating. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Covidien | Boulder | Colorado |
Lead Sponsor | Collaborator |
---|---|
Medtronic - MITG |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ME (mean error) of Respiration Rate values for each subject | 1-2 hours per subject | No |
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