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Comparison Study Between Nellcor Respiration Rate Technology (RRoxi) and Masimo Acoustic Respiration Rate (RRa)

NCT ID: NCT02657733

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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Respiratory Conditions for Adults

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Healthy volunteers

Respiration rate will be measured using several medical devices: Radical-7, Capnostream20p and Nellcor Bedside Respiratory Patient Monitoring System

Group Type OTHER

Radical-7

Intervention Type DEVICE

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).

Nellcor™ Bedside Respiratory Patient Monitoring System

Intervention Type DEVICE

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).

Capnostream 20p

Intervention Type DEVICE

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).

Interventions

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Radical-7

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).

Intervention Type DEVICE

Nellcor™ Bedside Respiratory Patient Monitoring System

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).

Intervention Type DEVICE

Capnostream 20p

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).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Herzog Hospital

OTHER

Sponsor Role collaborator

Oridion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michal Eisenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Herzog Hospital

Locations

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Herzog Hospital

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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10144939

Identifier Type: -

Identifier Source: org_study_id