Trending of Respiratory Rate Using the Nellcor™ Bedside Respiratory Patient Monitoring System
Completed
Conditions studied: Patients Prescribed Non-invasive Respiratory Monitoring
In brief
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.
Key facts
- Study ID
- NCT03593603
- Run by
- Medtronic - MITG
- People needed
- 37
- Starts
- 2018-07-11
- Expected to finish
- 2019-05-03
- Last updated by the study team
- 2019-05-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years or older.
- A patient who meets the weight requirement for the sensor (e.g. >30kg).
- 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.
- Patient is willing and able to provide written informed consent.
You may not qualify if…
- Expected length of stay is < 4 hours.
- Patient is pregnant or lactating.
- 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.
- Patient has an abnormality that may prevent proper application of the device.
- Patient is in atrial fibrillation.
- 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.
- Patient has an implanted pacemaker.
- Patient has excessive nail polish that cannot be removed or other dye or discoloration of the finger.
- Patient has diagnosed central apnea or diagnosed significant obstructive sleep apnea.
- Patient is currently using continuous positive airway pressure (CPAP).
- Patient is unwilling or unable to sign informed consent.
- Evidence that the patient cannot understand the purpose and risks of the study and would require a legally authorized representative to sign informed consent.
- Patient is participating in another potentially confounding clinical study.
- 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.
Where it is running
- St. John Health System — Tulsa, Oklahoma, United States
- MultiCare Institute for Research & Innovation — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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