Completed

Evaluation of Respiration Rate Parameters in a Hospital Population Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 2013
See protocol details

Summary

Principal SponsorMedtronic - MITG
Last updated: July 17, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01837537
Principal SponsorMedtronic - MITG
Last updated: July 17, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
18 years or older
A patient at the study site on a General Care Floor or General Surgery Care Floor
Male or female
Subject is willing and able to provide written consent
7 exclusion criteria prevent from participating
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 abnormality that may prevent proper application of the device
Subject has an implanted pacemaker
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

The Ohio State University Wexner Medical Center

Columbus, United StatesOpen The Ohio State University Wexner Medical Center in Google Maps
CompletedOne Study Center