- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02657720
Comparison Between Different Technologies That Measure Respiratory Rate
November 1, 2016 updated by: Oridion
Respiration rate is a critical vital sign that provides early detection of respiratory compromise and patient distress.
Continuous monitoring of respiration rate is performed in patients under different clinical conditions, including post-surgery or different respiratory diseases.
Clinician observation, pulse oximetry, and capnography are used individually or in combination to monitor ventilation during sedation and on post-surgical patients.
The American Society of Anesthesiologists mandates the monitoring of respiration by measuring end tidal carbon dioxide (RRetco2) during procedural sedation and anesthesia.
Other techniques for respiration rate measurement include different technologies such as acoustic respiratory rate (RRa).
The aim of this study is to compare the accuracy of RRetco2 and RRa under certain respiratory conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jerusalem, Israel, 91035
- Herzog Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 PTAF2 (flow meter)
|
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 respiratory rate.
The participant is connected to 3 monitors at the same time.
Capnostream20p measures respiratory rate using capnography (RRetCO2).
Comparison between 3 different monitors that measure respiratory rate.
The participant is connected to 3 monitors at the same time.
PTAF2 measures respiratory rate using flow pressure (RRflow).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The influence of different breathing rates.on the accuracy of respiratory rates in breaths per minute as measured by the tested devices compared to the reference device.
Time Frame: six months
|
Respiratory rate will be measured with the monitors Radical 7 device, Capnostream20p and PTAF2 (flow meter), the latter as a reference device and recorded in the following units: breaths per 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.
|
six months
|
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 the reference device.
Time Frame: six months
|
Respiratory rate will be measured with the monitors Radical 7 device, Capnostream20p and PTAF2 (flow meter), the latter as a reference device and recorded in the following units: 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.
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michal Eisenberg, MD, Herzog Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
August 17, 2015
First Submitted That Met QC Criteria
January 13, 2016
First Posted (Estimate)
January 18, 2016
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10141352
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Radical 7
-
Pamela PetersenCompleted
-
Manisa Celal Bayar UniversityCompleted
-
Trakya UniversityCompletedPerfusion Index | One-Lung Ventilation | Hypoxemia During Surgery | Oxygen Reserve Index | Pleth Variability IndexTurkey
-
OridionHerzog HospitalCompleted
-
Hopital FochCompleted
-
Cedars-Sinai Medical CenterMasimo CorporationTerminatedMajor Spine Surgery ProcedureUnited States
-
Zonguldak Bulent Ecevit UniversityCompletedFresh Flow | CarboxyhemoglobinemiaTurkey
-
Hospital Universitario Doctor PesetUnknownSphb Haemoglobin in Vivo ValidationSpain
-
Baskent University Ankara HospitalCompletedHyperoxia | Oxygen Reserve Index | Hyperoxemia | Fraction of Inspired OxygenTurkey
-
Samsun Education and Research HospitalCompleted