NCT04077593

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
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Rate

Interventions

Type	Name	Description
DEVICE	RRate Mobile app	Test respiratory rate with RRate application

Timeline

• Start date: 2018-10-21
• Primary completion: 2020-10-30
• Completion: 2020-11-30
• First posted: 2019-09-04
• Last updated: 2021-03-16

Locations

1 site across 1 country: France