Trending of Respiratory Rate Using the Nellcor™ Bedside Respiratory Patient Monitoring System



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:July 11, 2018
End Date:July 2019
Contact:Julie Goldberg, MSPH
Email:juile.l.goldberg@medtronic.com
Phone:303.305.2202

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An Evaluation of Plethysmography-based Trending of Respiratory Rate Using the Nellcor™ Bedside Respiratory Patient Monitoring System

This is an open-label, non-randomized, prospective, descriptive study of the Nellcor™ Bedside
Respiratory Patient Monitoring System using the Nellcor™ Respiration Rate parameter and
Nellcor™ Adult Respiratory Sensor The study is intended to gain further information in the
clinical space on the function of the Nellcor™ Respiration Rate parameter. The primary
objective is to describe spot check (e.g. manual observation) of respiration rate versus
cumulative automated counting (trend) of respiratory rate as measured using the Nellcor™
Bedside Respiratory Patient Monitoring System with the Nellcor™ Respiration Rate parameter.


Inclusion Criteria:

1. 18 years or older.

2. A patient who meets the weight requirement for the sensor (e.g. >30kg).

3. A patient at the study site on a General Care Floor (surgical or medical/non-surgical
to be distributed equally) and prescribed standard vital sign checks.

4. Patient is willing and able to provide written informed consent.

Exclusion Criteria:

1. Expected length of stay is < 4 hours.

2. Patient is pregnant or lactating.

3. Patient 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.

4. Patient has an abnormality that may prevent proper application of the device.

5. Patient is in atrial fibrillation.

6. Patient has a documented history of frequent premature atrial contractions (PACs) or
premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or
greater than 6 in 60 seconds within the past 3 months.

7. Patient has an implanted pacemaker.

8. Patient has excessive nail polish that cannot be removed or other dye or discoloration
of the finger.

9. Patient has diagnosed central apnea or diagnosed significant obstructive sleep apnea.

10. Patient is currently using continuous positive airway pressure (CPAP).

11. Patient is unwilling or unable to sign informed consent.

12. Evidence that the patient cannot understand the purpose and risks of the study and
would require a legally authorized representative to sign informed consent.

13. Patient is participating in another potentially confounding clinical study.

14. Extreme motion conditions such as patient is prescribed to walk more than once per
hour or is prescribed a medical device resulting in constant movement.
We found this trial at
2
sites
Tulsa, Oklahoma 74104
Principal Investigator: Michael S Charles, MD
Phone: 918-744-3426
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Tacoma, Washington 98405
Principal Investigator: Paul Amoroso, MD, MPH, CPE
Phone: 253-697-1301
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Tacoma, WA
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