- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02657733
Comparison Study Between Nellcor Respiration Rate Technology (RRoxi) and Masimo Acoustic Respiration Rate (RRa)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Jerusalem, Israel, 91035
- Herzog Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Without Clinical diagnosis of chronic obstructive pulmonary disease (COPD)
- Without Clinical diagnosis of heart disease.
Exclusion Criteria:
- Want to be excluded
- Breathing difficulties
- Unabling or unwilling to follow the protocol.
- Contact allergy to the adhesive neck sensor.
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Healthy volunteers
Respiration rate will be measured using several medical devices: Radical-7, Capnostream20p and Nellcor Bedside Respiratory Patient Monitoring System
|
Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time. Radical-7- measures respiratory rate according to acoustic respiratory rate (RRa). Comparison between 3 different monitors that measure repiratory rate. The participant is connected to 3 monitors at the same time. Nellcor™ Bedside Respiratory Patient Monitoring System - measures respiratory rate according to oximetry respiration rate (RRoxi).
Comparison between 3 different monitors that measure respiratory rate.
The participant is connected to 3 monitors at the same time.
Capnostream 20p- measures respiratory rate according to Capnography (RRetco2).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The influence of different breathing rates (normal breathing, tachypnea, and bradypnea) on the accuracy of respiratory rate in breaths per minute as measured by the tested devices compared to a reference device.
Time Frame: 6 hours
|
Respiratory rate will be measured with the monitors (Radical-7 device, Nellcor device, Capnostream20p device) and recorded in the following units: Breath/minute.
Differences in accuracy as compared to the reference device and differences in percentage of time in which the device was accurate will be analyzed offline.
|
6 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The influence of hearing or performing noises on the accuracy of respiratory rates (in breaths per minute) as measured by the tested devices compared to a reference device.
Time Frame: 6 months
|
Respiratory rate will be measured with the monitors (Radical-7 device ,Nellcor device, Capnostream20p device) in breaths per minute.
Differences in accuracy as compared to the reference device and differences in percentage of time in which the device indicated respiratory rate values will be analyzed offline.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michal Eisenberg, MD, Herzog Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10144939
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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