Clinical trial NCT01837537: Respiration Rate V2.0 in a Hospital Setting
Official title: Evaluation of Respiration Rate Parameters in a Hospital Population Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Rate
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2013-04-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteer subjects from a hospital setting on the general care floor or general surgical care floor

Brief summary: The purpose of this study is to meet the respiration rate accuracy specifications for the study pulse oximeter monitoring system (study device) in a hospitalized volunteer population when compared to established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR)(CO2).

Detailed description: Volunteer subjects from a hospital setting (see specific inclusion/exclusion criteria) over the age of 18, male and female, who provide written informed consent prior to the procedure, and are without any contact skin allergies to adhesives found in standard pulse oximetry sensors. A cross section of demographics - cardiovascular, respiratory, and metabolic type cases should be considered for a broad distribution of medical and surgical patients.

The study consists of measuring parameters related to respiration in hospitalized volunteers by means of the Bedside Respiratory Patient Monitoring System with RR V2.0 (Nightingale). The production-equivalent Nightingale device and multiparameter reference devices will be attached to the subject via sensors, nasal cannulas and ECG leads and the information from all devices will be captured continuously for up to 40 minutes to allow for at least 30 minutes of artifact free data 30 minutes.

Eligibility criteria: Inclusion Criteria:

* Male or female.
* 18 years or older.
* A patient at the study site on a General Care Floor or General Surgery Care Floor.
* Subject is willing and able to provide written consent.

Exclusion Criteria:

* Subject is younger than 18.
* Subject 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.
* Subject has an abnormality that may prevent proper application of the device.
* Subject is in atrial fibrillation.
* Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds.
* Subject has an implanted pacemaker.
* Subject is unwilling or unable to sign informed consent.

Primary outcomes:
measure: Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor
timeFrame: up to 40 minutes of continuous monitoring
Secondary outcomes:
measure: Mean Error (ME) +/- 1 Breath Per Minute, Max-N Sensor
timeFrame: up to 40 minutes of continuous monitoring
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Joshua Lumbley, MD
role: PRINCIPAL_INVESTIGATOR
References: