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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-11

Study Completion Date

2019-05-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Patients Prescribed Non-invasive Respiratory Monitoring

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Nellcor™ Bedside Respiratory Monitoring System

Intervention Type DEVICE

Nellcor™ Bedside Respiratory Patient Monitoring System with Nellcor™ Respiration Rate Software and the Nellcor™ Adult Respiratory Sensor to provide continuous respiration rate monitoring

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No