Status:
COMPLETED
A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Adolescent and Adult Patients in an Emergency Department
Lead Sponsor:
ResApp Health Limited
Conditions:
Asthma Exacerbation
COPD Exacerbation
Eligibility:
All Genders
12+ years
Brief Summary
Aim is to to demonstrate that the ResAppDx v2.0 algorithms provide an accurate diagnosis of respiratory disease in the study's clinical setting compared to a clinical adjudication committee's (CAC) di...
Eligibility Criteria
Inclusion
- Adolescents and adults aged 12 years and older:
- 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 14 days of presenting to the site.
Exclusion
- 1\. Parent or legal guardian is unwilling or unable to sign the study informed consent form.
- 2\. Adolescent patient 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 any medical contraindication to voluntary cough, including the following (only enroll if coughing spontaneously):
- a. Severe respiratory distress b. History of pneumothorax c. Eye, chest, or abdominal surgery within 3 months of presenting to the site 6. Hemoptysis within 1 month of presenting to the site. 7. Patient is too medically unstable to participate in study at the discretion of the treating clinician.
- 8\. Patient has a tracheostomy present and/or has a tracheostomy tube placed. 9. Patient is unable to provide at least 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 :
171 Patients enrolled
Trial Details
Trial ID
NCT06156462
Start Date
January 1 2024
End Date
February 29 2024
Last Update
March 4 2024
Active Locations (3)
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1
Addenbrookes Hospital
London, United Kingdom
2
The Royal London Hospital
London, United Kingdom
3
University College London Hospital
London, United Kingdom