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On the PhonE Respiratory rAte Study (OPERA)

Evaluation de la précision d'Une Mesure téléphonique de la fréquence Respiratoire à l'Aide d'Une Application Mobile - The OPERA Study (On the PhonE Respiratory rAte)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04077593
Acronym
OPERA
Enrollment
25
Registered
2019-09-04
Start date
2018-10-21
Completion date
2020-11-30
Last updated
2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Rate

Keywords

Respiratory Rate, Telemedicine, Dyspnea, Emergencies

Brief summary

Introduction. The increasing use of telephone medical advice requires the development of telemedicine tools to assess the patient's severity. Respiratory rate (RR) is a simple vital parameter and is often associated with morbidity and mortality of patients. There is no standardized measure of RR by telephone. Objective: The investigators wanted to evaluate the RR measurement by phone using a smartphone application called RRate. Methods. Adults who have been admitted for less than 6 hours to the emergency department after calling Center 15 and whose main reason for consultation is dyspnea will be included. Patients with non-invasive or tracheotomized ventilation will be excluded. The main objective will be to compare by Bland-Altman method the accuracy of the RRate measurement by phone to a one-minute RR measurement at patient's bedside. Secondary endpoints will evaluate the length of RR measurement according to the different methods used; measurement failure criteria; the accuracy of different measurement techniques (RRate at patient's bedside, impedancemetry, traditional measurement during 15s or 30s). Expected Results. The accuracy of the RR measurement by RRate over the telephone should be within the limits of agreement. The measurement time should be shorter with the RRate application than with traditional methods. However, the measurement by telephone should not always be feasible in patients with mild dyspnea or with poorly audible breathing.

Interventions

DEVICERRate Mobile app

Test respiratory rate with RRate application

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \>18yo * Dyspnea as main reason for consultation * Regulated by Centre 15 * Admitted for less than 6hours at emergency department

Exclusion criteria

* Non invasive or tracheotomized ventilation * Cognitive impairment * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
RRate app on the phone precision1 minuteTo compare withBland-Altman analysis the accuracy of the RRate measurement by phone to a one-minute respiratory rate measurement at patient's bedside

Secondary

MeasureTime frameDescription
Efficiency1 minutelength of RR measurement according to the different methods used
Measurement failure criteria by different Rrate methods (by phone, next to the patient and the reference method)1 minuteWether coughing, talking during measurement, phone hold by another person, has an impact on measurement possibility. The gap between the measurement by different RRate methods (by phone, next to the patient and the reference method)
Accuracy1 minuteBland Altman analysis : between one minute measurement at patient's bedside and other measurements : RRate app at patient's bedside, impedancemetry, traditional measurement during 15 seconds or 30 seconds
Clinical impact1 minuteqSOFA (sequential Organ Failure Assesment score) obtained with different measurement of the RRate at 60 second
Reproducibility1 minuteCoefficient of variation and Intra-class correlation, of respiratory rate measured twice with : RRate app on the phone, RRate app at patient's bedside, 15 seconds measurement.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026