NCT02657720

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_4 healthy

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1 month

First QC Date

August 17, 2015

Last Update Submit

November 1, 2016

Conditions

Healthy

Keywords

Respiratory Conditions for Adults

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (1)

  • 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.

    six months

Study Arms (1)

Healthy volunteers

OTHER

Respiration rate will be measured using several medical devices: Radical-7, Capnostream20p and PTAF2 (flow meter)

Device: Radical 7Device: Capnostream20pDevice: PTAF2

Interventions

Radical 7DEVICE

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).

Healthy volunteers
Capnostream20pDEVICE

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).

Healthy volunteers
PTAF2DEVICE

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).

Also known as: Flowmeter
Healthy volunteers

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Without Clinical diagnosis of chronic obstructive pulmonary disease (COPD)
  • Without Clinical diagnosis of heart disease.

You may not qualify if:

  • Want to be excluded
  • Breathing difficulties
  • Unabling or unwilling to follow the protocol.
  • Contact allergy to the adhesive neck sensor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzog Hospital

Jerusalem, 91035, Israel

Location

MeSH Terms

Interventions

Flowmeters

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and Supplies

Study Officials

  • Michal Eisenberg, MD

    Herzog Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2015

First Posted

January 18, 2016

Study Start

July 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

IL(1)