Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373939
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-10
Brief Title:
Performance and Safety of the Pneumoscope Device in Adults and Children
Sponsor:
Pediatric Clinical Research Platform
Organization:
Pediatric Clinical Research Platform
Study Overview
Official Title:
Pivotal Study of the Performance and Safety of the Pneumoscope Device in Adults and Children
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 auscultations 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 Pneumoscopes 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
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 Pneumoscopes 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None