Performance and Safety of the Pneumoscope Device in Adults and Children
Pivotal Study of the Performance and Safety of the Pneumoscope Device in Adults and Children
Pediatric Clinical Research Platform
225 participants
Apr 15, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- Patients will be recruited from the pediatric and adult clinical departments of the Geneva University Hospitals.
- 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 Criteria8
- 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.
Interventions
Two 30-second recordings will be made using CE-marked Littmann® CORE digital stethoscopes and the Pneumoscope at two bilateral lung positions on the posterior chest wall, focusing on the lower lobes. Spectral comparison and audio quality indices will be assessed between the Pneumoscope and the Littmann® CORE digital stethoscope. Comparator: The Gold Standard Littmann® CORE picks up sounds, such as heart and lung sounds, from a patient's body. After amplification and filtering, the sounds are sent to the user through a binaural headset. The stethoscope chest piece is designed for use with adult, pediatric, and infant patients.
Pulse oximetry and heart rate will be measured using the CE-marked Masimo Rad-G® and iHealth® Air oximeters, as well as the Pneumoscope's built-in oximeter. Agreement between the Pneumoscope's oximeter and the reference oximeters will be evaluated. Measurement will take 30 second on the right index finger. Comparators: 1. The Gold Standard Masimo Rad-G® sensor is indicated for the continuous noninvasive peripheral monitoring of arterial oxygen saturation (SpO2) and pulse rate. Its use consists in positioning the emitting window of the sensor attachment envelope on the top of the finger nail bed, while the detector is placed opposite the emitter on the other side of the same finger. 2. The Gold Standard iHealth® Air works by projecting two beams of light through a clip with a transmitter and a detector that is placed around a finger, nail side down and screen side up.
Comparison of body temperature measurements between the Pneumoscope's built-in thermometer and Gold Standard thermometers (Terumo® C205 and VisioFocus Pro 06480). Comparators: 1. The Gold Standard Terumo® C205 is an axillary thermometer. Its use consists in placing the probe in the armpit, then lowering the arm and holding the device firmly until the temperature is stabilised and the temperature is read and displayed on the thermometer screen. 2. The Gold Standard VisioFocus Pro 06480 is an infrared thermometer that detects the infrared radiation naturally emitted by the body and in particular from the human forehead. Its use consists in holding the thermometer close to the forehead but without direct contact with the skin. The temperature reading is then projected on the patient's forehead using a symbol system.
Locations(1)
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NCT06373939