Pivotal Study of the Performance and Safety of the Pneumoscope Device in Adults and Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiratory Diseases
- Sponsor
- Pediatric Clinical Research Platform
- Enrollment
- 225
- Locations
- 1
- Primary Endpoint
- Evaluation of Pneumoscope's built-in sensors
- Status
- Recruiting
- Last Updated
- last year
Overview
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 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.
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 smoke. Asthma is the most prevalent chronic disease in children, while pneumonia is the leading cause of death in children under 5. Respiratory infections are prominent in pediatric outpatient clinics, especially in low- and middle-income countries. Accurate diagnosis and risk assessment are crucial for effective management. Clinicians utilize three key tools: the stethoscope for auscultation, detecting abnormal breathing sounds; the pulse oximeter, indicating oxygen deficiency in inflamed lungs; and the thermometer, primarily for fever-related infections like pneumonia. Auscultation, while quick and non-invasive, suffers from user-dependent subjective interpretation, as highlighted by studies reporting low correct response rates, especially among non-pulmonologists. Pulmonary auscultation's sensitivity and specificity are notably low, particularly in unilateral or focal changes. Pulse oximetry, utilizing harmless light wavelengths, measures oxygenated hemoglobin concentration, with a saturation below 92% indicating hypoxia, albeit with reduced accuracy below 90%. Thermometers measure body temperature, with rectal measurement considered the gold standard in children, although non-contact methods remain contentious The use of the Pneumoscope, a digital medical device, could address the above challenge. The Pneumoscope is designed to enhance respiratory disease diagnosis and provide heart rate, respiratory rate, pulse oximetry, and body temperature data. This project aims to evaluate its performance against gold standards in lung sound processing, pulse oximetry, and body temperature measurement. Furthermore, the Pneumoscope is envisioned to integrate artificial intelligence (AI) for future applications. Data on breath sounds, oximetry, heart rate, and temperature from patients with respiratory diseases will inform AI algorithms for disease recognition and risk assessment. Ultimately, this technology could enable remote diagnosis and follow-up, particularly beneficial for patients in low- and middle-income countries or with limited mobility. However, the current study focuses solely on assessing the Pneumoscope's performance as a standard digital stethoscope with integrated temperature and oximetry sensors, aiming to establish agreement with established clinical tools for digital lung auscultation, pulse oximetry, heart rate, and body temperature measurement. This is a single center, open, non-controlled investigation that will be conducted at the University Hospitals of Geneva, Switzerland. This will be a non-inferiority study between Pneumoscope and CE marked comparable medical devices in children and adults.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Evaluation of Pneumoscope's built-in sensors
Time Frame: During procedure, i.e. 20 minutes per patient for both out- and inpatients.
To be used in patients and certified by competent authorities the performance of Pneumoscope has to be at least equal as comparable devices on the market. Performances of digital audio quality, as well as pulse oximetry, heart rate and temperature measurements by the Pneumoscope will be compared to CE certified similar medical devices used as gold-standards tools. Hence, the primary objective is to evaluate whether the three built-in sensors into the Pneumoscope are equivalent to CE marked Gold Standards: 1. Spectral comparison and other audio quality indices of recordings with the Pneumoscope and a commercially available digital stethoscope (Littmann® CORE digital stethoscope). 2. Agreement between the Pneumoscope thermometer and reference thermometers (Terumo® C205 and VisioFocus Pro® 06480). 3. Agreement between the Pneumoscope pulse oximeter (for blood oxygen saturation and heart rate) and reference oximeters (Masimo Rad-G® and iHealth® Air).
Secondary Outcomes
- Collect audio records of lung sounds for AI models training and sensor calibration(During procedure, i.e. 20 minutes per patient for both out- and inpatients.)
- Body temperature(During procedure, i.e. 20 minutes per patient for both out- and inpatients.)
- Pulse oximetry(During procedure, i.e. 20 minutes per patient for both out- and inpatients.)