- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04077593
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.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Isere
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La Tronche, Isere, Frankrig, 38700
- Grenoble University Hospital
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Andet
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
RRate app on the phone precision
Tidsramme: 1 minute
|
To compare withBland-Altman analysis the accuracy of the RRate measurement by phone to a one-minute respiratory rate measurement at patient's bedside
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1 minute
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Efficiency
Tidsramme: 1 minute
|
length of RR measurement according to the different methods used
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1 minute
|
Measurement failure criteria by different Rrate methods (by phone, next to the patient and the reference method)
Tidsramme: 1 minute
|
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
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Accuracy
Tidsramme: 1 minute
|
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
Tidsramme: 1 minute
|
qSOFA (sequential Organ Failure Assesment score) obtained with different measurement of the RRate at 60 second
|
1 minute
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Reproducibility
Tidsramme: 1 minute
|
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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Maxime MD Maignan, PhD, University Hospital, Grenoble
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 38RC18.181
- n°IDRCB: 2018-A02039-46 (Anden identifikator: ID RCB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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