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

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.

Study Overview

• Status: Completed
• Conditions: Patients Prescribed Non-invasive Respiratory Monitoring
• Intervention / Treatment: Device: Nellcor™ Bedside Respiratory Monitoring System

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • St. John Health System
  • Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare Institute for Research & Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be included who provide informed consent, who are prescribed non-invasive respiratory monitoring via spot check vital signs at least every 4 hours and are without any contact skin allergies to adhesives found in standard pulse oximetry sensors. Potential subjects are those who will be admitted to the General Care Floor. The subject pool will be approximately divided equally between medical/non-surgical and surgical patients.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nellcor™ Bedside Respiratory Monitoring System; Patients on the general care floor who are prescribed non-invasive respiratory monitoring via spot check vital signs at least every 4 hours	Device: Nellcor™ Bedside Respiratory Monitoring System; Nellcor™ Bedside Respiratory Patient Monitoring System with Nellcor™ Respiration Rate Software and the Nellcor™ Adult Respiratory Sensor to provide continuous respiration rate monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement of RR measured by spot checks vs continuous monitoring	Bias and a range of agreement of the differences between RR measured by spot checks and RR measured using the Nellcor™ Bedside Respiratory Patient Monitoring System	at least 4 hours

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Paul J Amoroso, MD, MultiCare Institute for Research and Innovation

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 11, 2018
• Primary Completion (ACTUAL): May 3, 2019
• Study Completion (ACTUAL): May 3, 2019

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (ACTUAL): July 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: MDT17002NELLRR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No