Pulse Oximetry- Evaluating Resp Rate- PCBA-1

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791582
• Other study ID #: COVMOPR0304
• Status: Completed
• Phase: N/A
• First received: November 29, 2012
• Last updated: December 5, 2013
• Start date: October 2012
• Est. completion date: October 2012

Study information

• 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

Clinical Trial Summary

To assess performance of resp rate parameter in a monitoring system PCBA-1

Recruitment information / eligibility

• 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Subjects

Locations

Country	Name	City	State
United States	Covidien	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ME (mean error) of Respiration Rate values for each subject		1-2 hours per subject	No