Performance and Safety of the Pneumoscope Device in Adults and Children

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 particularly useful tools to identify these conditions when assessing the patient's status: the stethoscope, the pulse oximeter, and the thermometer. The Pneumoscope is an all-in-one device including a digital stethoscope, a pulse oximeter, and a thermometer. This study aims to assess the performance and safety of the Pneumoscope in recording respiratory sounds, body temperature, non-invasive blood oxygen saturation levels and heart rate in children and adults.

Eligibility

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.

Conditions5

Browse More Trials