On the PhonE Respiratory rAte Study (OPERA)

NCT04077593 | Completed

• 2 other identifiers: 38RC18.181n°IDRCB: 2018-A02039-46
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Rate

Keywords

Respiratory Rate; Telemedicine; Dyspnea; Emergencies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Interventions

RRate Mobile app DEVICE

Test respiratory rate with RRate application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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"

You may qualify if:

• Age \>18yo
• Dyspnea as main reason for consultation
• Regulated by "Centre 15"
• Admitted for less than 6hours at emergency department

You may not qualify if:

• Non invasive or tracheotomized ventilation
• Cognitive impairment
• Pregnancy

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble University Hospital

La Tronche, Isere, 38700, France

Location

MeSH Terms

Conditions

Dyspnea; Emergencies

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Maxime MD Maignan, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: September 4, 2019
• Study Start: October 21, 2018
• Primary Completion: October 30, 2020
• Study Completion: November 30, 2020
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)