On the PhonE Respiratory rAte Study (OPERA)

Respiratory Rate Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077593
• Other study ID #: 38RC18.181
• Secondary ID: n°IDRCB: 2018-A0
• Status: Completed
• Start date: October 21, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: March 2021
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Rate

Intervention

Device:
• RRate Mobile app
Test respiratory rate with RRate application

Locations

Country	Name	City	State
France	Grenoble University Hospital	La Tronche	Isere

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficiency	length of RR measurement according to the different methods used	1 minute
Secondary	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
Secondary	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
Secondary	Clinical impact	qSOFA (sequential Organ Failure Assesment score) obtained with different measurement of the RRate at 60 second	1 minute
Secondary	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