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

Completed

• Conditions: Patients Prescribed Non-invasive Respiratory Monitoring
• Interventions: Device: Nellcor™ Bedside Respiratory Monitoring System

• Registration Number: NCT03593603
• Lead Sponsor: Medtronic - MITG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-07-10
• Study Start: 2018-07-11
• Study First Posted: 2018-07-20
• Status Verified: 2019-05
• Primary Completion: 2019-05-03
• Study Completion: 2019-05-03
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nellcor™ Bedside Respiratory Monitoring System	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

Primary Outcome Measures

Name	Time	Method
Agreement of RR measured by spot checks vs continuous monitoring	at least 4 hours	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

Trial Locations

Locations (2)

MultiCare Institute for Research & Innovation; 🇺🇸 Tacoma, Washington, United States

St. John Health System; 🇺🇸 Tulsa, Oklahoma, United States