UnknownNot Applicable

Performance and Safety of the Pneumoscope Device in Adults and Children

Switzerland225 participantsStarted 2024-04-15

Plain-language 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.

Who can participate

Age range

1 Year

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluation of Pneumoscope's built-in sensors

Timeframe: During procedure, i.e. 20 minutes per patient for both out- and inpatients.

Trial details

NCT IDNCT06373939

SponsorPediatric Clinical Research Platform

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Contact for this trial

Johan N Siebert, MD

(0)79 553 40 72 Johan.Siebert@hcuge.ch

View on ClinicalTrials.gov More Respiratory Diseases trials