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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Asthma in Children; Bronchiolitis; Lower Respiratory Tract Infection; Croup; Reactive Airway Disease
• Intervention / Treatment: Device: ResAppDx v.20

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • Birmingham Children's Hospital
  • Bristol, United Kingdom
    • Bristol Royal Hospital of Children
  • Leicester, United Kingdom
    • Leicester Royal Infirmary
  • London, United Kingdom
    • The Royal London Hospital
  • London, United Kingdom
    • Evelina London Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects aged from 29 days to less than 12 years of age presenting to a study site with signs or symptoms of respiratory disease including rhinorrhea, cough, wheeze, stridor, work of breathing, cyanosis, additional auscultatory noises (crepitations), chest in-drawing/retractions or fast breathing.

Description

Inclusion Criteria:

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

  1. 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.
  2. Onset of symptoms must have occurred within the past 14 days.

Exclusion Criteria:

1. Parent or legal guardian is unwilling or unable to sign the study informed consent form.
2. 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.
3. Patient requires mechanical ventilatory support (including invasive, CPAP, or BiPAP) or high flow nasal cannula
4. Patient has a history of structural airways abnormalities, tracheobronchomalacia, or vocal cord abnormalities (e.g. laryngomalacia, tracheomalacia, or bronchomalacia)

5. 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
6. Patient is too medically unstable to participate in study per treating clinician
7. Patient has a tracheostomy present or tube placed
8. Patient is unable to provide at 5 coughs (voluntary and/or spontaneous)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Paediatric Patients	Device: ResAppDx v.20; Software application used to aid diagnosis of respiratory disorders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of ResAppDx v2.0 compared to clinical adjudication panel	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)	6 months

Collaborators and Investigators

• Sponsor: ResApp Health Limited

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: November 26, 2023
• First Submitted That Met QC Criteria: November 26, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Emergencies; Respiratory Tract Infections; Bronchiolitis; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 19002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No