Status:
COMPLETED
A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Paediatric Patients in an Emergency Department
Lead Sponsor:
ResApp Health Limited
Conditions:
Croup
Bronchiolitis
Eligibility:
All Genders
29-12 years
Brief Summary
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 Com...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 29 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06156436
Start Date
January 1 2024
End Date
February 29 2024
Last Update
March 4 2024
Active Locations (5)
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1
Birmingham Children's Hospital
Birmingham, United Kingdom
2
Bristol Royal Hospital of Children
Bristol, United Kingdom
3
Leicester Royal Infirmary
Leicester, United Kingdom
4
Evelina London Children's Hospital
London, United Kingdom