A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Paediatric Patients in an Emergency Department

Aim of study is to demonstrate that the ResAppDx v2.0 algorithms provide an accurate diagnosis of paediatric respiratory disease in the study's clinical setting compared to a Clinical Adjudication Committee's (CAC) diagnosis; and to establish a baseline for the resource use and cost of current care pathways for paediatric respiratory disease diagnosis in an emergency department. Eligible subjects/parents will be assented/consented, enrolled and their subject reported signs/symptoms of respiratory disease will be recorded in the study electronic case report form (eCRF).The enrolled subject's cough sounds will be captured (5 cough sounds are required) using the ResAppDx v2.0 Investigational Device (ID) software installed on a study smartphone; cough sounds may be voluntary and/or involuntary/spontaneous. As this is an observational study the treating team will be blinded to the ResAppDx v2.0diagnoses. Additional medical information will be collected from the treating team, from the subject/parent and from the subject's medical record. No follow-up/subsequent visits with the subject will be required by the study. As an efficacy comparator, a CAC will determine the final clinical diagnosis for each enrolled subject using the disease case definitions, eCRF data, the subject's medical record and cough sound recordings.Information on time and scope of tests and consults ordered by the treating team will be recorded to set a baseline for resource use and cost and time of current standard of care treatment/assessment procedures. This data will allow future health economics analyses to be performed.The blinded ResAppDx v2.0diagnoses will be unblinded after database lock and sensitivity and specificity will be calculated for the ResAppDx v2.0diagnoses compared to agreement with the CAC's final clinical diagnoses for this cohort.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Croup Asthma in Children Bronchial Diseases Bronchiolitis Bronchitis Chronic Disease Disease Attributes Infections Laryngeal Diseases Laryngitis Lower Respiratory Tract Infection Lung Diseases Lung Diseases, Obstructive Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pulmonary Disease, Chronic Obstructive Reactive Airway Disease Respiratory Tract Diseases Respiratory Tract Infections

Age range

29 day–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Birmingham Children's Hospital, Birmingham, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Infants and children, aged from 29 days to less than 12 years of age.

Presenting to the study site with current signs or symptoms of rhinorrhea, cough, wheeze, stridor, increased work of breathing, cyanosis, additional auscultatory noises (crepitations), or low oximetry levels.
Onset of symptoms must have occurred within the past 14 days.

Exclusion criteria

Parent or legal guardian is unwilling or unable to sign the study informed consent form.
A child who, in the opinion of the investigator, is able to provide assent based on their age, maturity or psychological state is unwilling or unable to sign the study assent form.
Patient requires mechanical ventilatory support (including invasive, CPAP, or BiPAP) or high flow nasal cannula
Patient has a history of structural airways abnormalities, tracheobronchomalacia, or vocal cord abnormalities (e.g. laryngomalacia, tracheomalacia, or bronchomalacia)
Patient has a medical contraindication to voluntary cough, including the following (only enroll if coughing spontaneously)

Severe respiratory distress
History of pneumothorax
Eye, chest, or abdominal surgery in past 3 months
Hemoptysis in the past month
Patient is too medically unstable to participate in study per treating clinician
Patient has a tracheostomy present or tube placed
Patient is unable to provide at 5 coughs (voluntary and/or spontaneous)

Treatment and study plan

ResAppDx v.20

Device

Software application used to aid diagnosis of respiratory disorders

Primary outcomes

Efficacy of ResAppDx v2.0 compared to clinical adjudication panel

Time frame: 6 months
Efficacy will be compared to the diagnosis formed by consensus of the Clinical Adjudication Committee (CAC) and evaluated using sensitivity and specificity of ResAppDx v2.0 algorithms ("Index Test") to diagnose and rule out the following conditions:
- croup;
- bronchiolitis (for patients less than 2 years old only);
- asthma / reactive airway disease (RAD);
- pneumonia and
- lower respiratory tract disease (LRTD)

Sponsors and collaborators

Lead sponsor

ResApp Health Limited

Industry

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Dec 5, 2023
Registry last updated: Mar 4, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed