Pulse Oximetry- Evaluating Resp Rate- PCBA-1

Respiration Rate Parameter Studies in Healthy Volunteers Using a Bedside Respiratory Patient Monitoring System With the Multi-Functional Patient Monitoring PCBA-1

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01791582

Enrollment

Registered

2013-02-15

Start date

2012-10-31

Completion date

2012-10-31

Last updated

2013-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief summary

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

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
ME (mean error) of Respiration Rate values for each subject	1-2 hours per subject

Countries

United States

Outcome results