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Completed

NCT Number: NCT04077593

On the PhonE Respiratory rAte Study (OPERA)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Grenoble University Hospital

La Tronche, Isere, 38700, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RRate Mobile app

Device

Test respiratory rate with RRate application

Primary outcomes

  1. RRate app on the phone precision

    Time frame: 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 outcomes

  1. Efficiency

    Time frame: 1 minute

    length of RR measurement according to the different methods used

  2. Measurement failure criteria by different Rrate methods (by phone, next to the patient and the reference method)

    Time frame: 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)

  3. Accuracy

    Time frame: 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

  4. Clinical impact

    Time frame: 1 minute

    qSOFA (sequential Organ Failure Assesment score) obtained with different measurement of the RRate at 60 second

  5. Reproducibility

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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)

Acronym: OPERA

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 4, 2019
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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