CroupNCT06156436
A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Paediatric Patients in an Emergency Department
An observational study of Croup and Bronchiolitis, run by ResApp Health Limited at 5 sites in United Kingdom.
Trial 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 Committee's (CAC) diagnosis; and to establish a baseline for the resource use and cost of current care pathways for… Read more about this study
- Who is it for?
- Ages 29 days to 12 years
- Conditions the study is for
- Croup, Bronchiolitis, Asthma in Children
- What is being tested?
- ResAppDx v.20
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 1 Jan 2024to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Birmingham Children's Hospital
Birmingham
Bristol Royal Hospital of Children
Bristol
Leicester Royal Infirmary
Leicester
Evelina London Children's Hospital
London
The Royal London Hospital
London
About this study
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.
- Conditions
- Croup, Bronchiolitis, Asthma in Children, Reactive Airway Disease, Pneumonia, Lower Respiratory Tract Infection
- Being tested
- ResAppDx v.20
- Medical subject headings
- Croup, Bronchiolitis, Pulmonary Disease, Chronic Obstructive, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResAppDx v.20Device
Software application used to aid diagnosis of respiratory disorders
| Study group | Role | What they receive |
|---|---|---|
| Paediatric Patients | Not described Receives: Device: ResAppDx v.20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Jan 2024
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CroupStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResApp Health Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156436
- Sponsor's protocol ID
- 19002
- Status last verified
- Feb 2024
- First submitted
- 26 Nov 2023
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Paediatric Patients in an Emergency Department
- ClinicalTrials.gov ID
- NCT06156436
- Acronym / sponsor ID
- 19002
- Conditions
- Croup, Bronchiolitis, Asthma in Children, Reactive Airway Disease, Pneumonia, Lower Respiratory Tract Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- ResApp Health LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paediatric Patients | – | Device: ResAppDx v.20 |
Who may qualify
- Ages
- 29 days to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Infants and children, aged from 29 days to less than 12 years of age.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResAppDx v.20Software application used to aid diagnosis of respiratory disorders | Device | Paediatric Patients |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Croup
RecruitingObservational study
Complicated Infections in Otorhinolaryngology
Sinusitis, Otitis
Recruiting
Impact of a Multimodal Intervention on Antibiotic Prescribing for Respiratory Infections in Primary Care
Angina, Acute Bronchiolitis
RecruitingPhase 3
VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma
Asthma, Respiratory Tract Infections
RecruitingPhase 3
Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma
Asthma, Respiratory Tract Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Croup and Bronchiolitis, run by ResApp Health Limited at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of ResAppDx v2.0 compared to clinical adjudication panel (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.