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)

On the PhonE Respiratory rAte Study (OPERA)

Sponsors

Lead sponsor: University Hospital, Grenoble

Source University Hospital, Grenoble
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.

Overall Status Recruiting
Start Date October 21, 2018
Completion Date February 29, 2020
Primary Completion Date January 30, 2020
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
RRate app on the phone precision 1 minute
Secondary Outcome
Measure Time Frame
Efficiency 1 minute
Measurement failure criteria by different Rrate methods (by phone, next to the patient and the reference method) 1 minute
Accuracy 1 minute
Clinical impact 1 minute
Reproducibility 1 minute
Enrollment 25
Condition
Intervention

Intervention type: Device

Intervention name: RRate Mobile app

Description: Test respiratory rate with RRate application

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Maxime MD Maignan, PhD Principal Investigator University Hospital, Grenoble
Overall Contact

Last name: Maxime MD Maignan, PhD

Phone: 0033476766784

Email: [email protected]

Location
facility status contact Grenoble University Hospital Maxime Maignan, PhD 00334 76 76 67 84 [email protected]
Location Countries

France

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Acronym OPERA
Patient Data No
Study Design Info

Observational model: Other

Time perspective: Prospective

Source: ClinicalTrials.gov