On the PhonE Respiratory rAte Study (OPERA) (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)

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Rate
• Intervention / Treatment: Device: RRate Mobile app

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• France
  • Isere
    • La Tronche, Isere, France, 38700
      • Grenoble University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Every adult patient admitted to Grenoble University Hospital's emergency department whose main reason for consultation is dyspnea and who's been dispatched by "Centre 15"

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RRate app on the phone precision	To compare withBland-Altman analysis the accuracy of the RRate measurement by phone to a one-minute respiratory rate measurement at patient's bedside	1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficiency	length of RR measurement according to the different methods used	1 minute
Measurement failure criteria by different Rrate methods (by phone, next to the patient and the reference method)	Wether 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)	1 minute
Accuracy	Bland 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	1 minute
Clinical impact	qSOFA (sequential Organ Failure Assesment score) obtained with different measurement of the RRate at 60 second	1 minute
Reproducibility	Coefficient 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.	1 minute

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Maxime MD Maignan, PhD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2018
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: September 2, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Telemedicine; Dyspnea; Respiratory Rate; Emergencies
• Other Study ID Numbers: 38RC18.181; n°IDRCB: 2018-A02039-46 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No