Status:
RECRUITING
Performance and Safety of the Pneumoscope Device in Adults and Children
Lead Sponsor:
Pediatric Clinical Research Platform
Collaborating Sponsors:
University Hospital, Geneva
Conditions:
Respiratory Diseases
Pneumonia
Eligibility:
All Genders
1+ years
Phase:
NA
Brief Summary
Respiratory diseases are associated with high morbidity and mortality worldwide. Proper diagnosis and risk assessment of these conditions are essential for optimal management. Clinicians use three par...
Detailed Description
Respiratory diseases affect over 500 million people globally, ranking third in causes of death. Chronic obstructive pulmonary diseases impact 251 million individuals due to air pollution and tobacco s...
Eligibility Criteria
Patients will be recruited from the pediatric and adult clinical departments of the Geneva University Hospitals.
Inclusion Criteria:
- Age > 1 year old.
- Healthy patients on the day of auscultation OR
- Patients with lower respiratory tract diseases (e.g., bronchitis, pneumonia, etc.). OR
- Patients with low (i.e., <92%) pulse oximetry values (e.g., cyanotic heart defect such as tetralogy of Fallot, transposition of great vessels, etc.). AND / OR
- Patients with fever >38.0°C.
- And for all: Information and written consent of the patient or a legal representative.
Exclusion Criteria:
- Refusal of consent.
- Clinical signs of severity: acute hypoxia, hypercapnia, acute respiratory failure, acute circulatory failure.
- Immune disorder, primary ciliary dyskinesia, antecedent of neonatal bronchopulmonary dysplasia.
- Contraindications and limitations of the MD as described in the instructions for use.
- Contraindications to the class of medical devices being studied, e.g. known hypersensitivity or allergy to the device material.
- Clinically significant concomitant disease states.
- Inability to follow the study procedures, e.g. due to language problems, psychological disorders, dementia, etc.
- Participation in another study with an investigational drug or other medical device within 30 days prior to and during the present study.
Key Trial Info
Start Date :
April 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT06373939
Start Date
April 15 2024
End Date
December 31 2024
Last Update
July 3 2024
Active Locations (1)
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1
Geneva University Hospitals
Geneva, Switzerland, 1205