On the PhonE Respiratory rAte Study (OPERA)

Completed

• Conditions: Respiratory Rate

• Registration Number: NCT04077593
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-21
• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2019-09-02
• Study First Posted: 2019-09-04
• Primary Completion: 2020-10-30
• Study Completion: 2020-11-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RRate app on the phone precision	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

Secondary Outcome Measures

Name	Time	Method
Efficiency	1 minute	length of RR measurement according to the different methods used
Accuracy	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
Clinical impact	1 minute	qSOFA (sequential Organ Failure Assesment score) obtained with different measurement of the RRate at 60 second
Reproducibility	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.
Measurement failure criteria by different Rrate methods (by phone, next to the patient and the reference method)	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)

Trial Locations

Locations (1)

Grenoble University Hospital; 🇫🇷 La Tronche, Isere, France