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

Patients Prescribed Non-invasive Respiratory Monitoring Clinical Trial

— RespRate  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03593603
• Other study ID #: MDT17002NELLRR
• Status: Completed
• Start date: July 11, 2018
• Est. completion date: May 3, 2019

Study information

• Verified date: May 2019
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 3, 2019
• Est. primary completion date: May 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Patients Prescribed Non-invasive Respiratory Monitoring

Intervention

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

Locations

Country	Name	City	State
United States	MultiCare Institute for Research & Innovation	Tacoma	Washington
United States	St. John Health System	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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