Clinical trial NCT04077593: On the PhonE Respiratory rAte Study (OPERA)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Rate
Keywords: Respiratory Rate
Telemedicine
Dyspnea
Emergencies
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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"

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.


Eligibility 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

Primary outcomes:
measure: RRate app on the phone precision
timeFrame: 1 minute
Secondary outcomes:
measure: Efficiency
timeFrame: 1 minute
measure: Measurement failure criteria by different Rrate methods (by phone, next to the patient and the reference method)
timeFrame: 1 minute
measure: Accuracy
timeFrame: 1 minute
measure: Clinical impact
timeFrame: 1 minute
measure: Reproducibility
timeFrame: 1 minute
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Grenoble University Hospital
state: Isere
Study officials:
affiliation: University Hospital, Grenoble
name: Maxime MD Maignan, PhD
role: PRINCIPAL_INVESTIGATOR
References: