Respiratory DiseasesNCT06373939
Performance and Safety of the Pneumoscope Device in Adults and Children
A study testing Digital lung auscultation, Pulse oximetry measurement and Non invasive body temperature measurement in people with Respiratory Diseases and Pneumonia, run by Pediatric Clinical Research Platform at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Diseases, Pneumonia, Asthma
- What is being tested?
- Digital lung auscultation, Pulse oximetry measurement and Non invasive body temperature measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Apr 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, 1205
Alain Gervaix, Prof, (0)22 372 45 55 ext. +41, Alain.Gervaix@hcuge.ch
Johan Siebert, MD, (0)79 553 40 72 ext. +41, Johan.Siebert@hcuge.ch
About this study
Official title: Pivotal Study of the Performance and Safety of the Pneumoscope Device in Adults and Children
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.
Read the 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.
- Conditions
- Respiratory Diseases, Pneumonia, Asthma, Cyanotic Heart Disease
- Being tested
- Digital lung auscultation, Pulse oximetry measurement, Non invasive body temperature measurement
- Keywords
- Stethoscopes, Oxygen Saturation, Thermometers, Digital Health, Auscultation
- Medical subject headings
- Respiratory Tract Diseases, Pneumonia, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital lung auscultationDevice
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 measurementDevice
Also called Oximeters
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:
- 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.
- 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.
Non invasive body temperature measurementDevice
Also called Thermometers
Comparison of body temperature measurements between the Pneumoscope's built-in thermometer and Gold Standard thermometers (Terumo® C205 and VisioFocus Pro 06480).
Comparators:
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Children (>1 year old) and adult patients | Experimental | Patients with various respiratory conditions, such as asthma or pneumonia, along with healthy individuals, will be targeted to assess the Pneumoscope's performance under clinical conditions. Additionally, patients with lower blood oxygen saturation levels, such as those with cyanotic heart defects like tetralogy of Fallot, will also be included Receives: Device: Digital lung auscultation; Device: Pulse oximetry measurement; Device: Non invasive body temperature measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Pneumoscope's built-in sensors
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:
- Spectral comparison and other audio quality indices of recordings with the Pneumoscope and a commercially available digital stethoscope (Littmann® CORE digital stethoscope).
- Agreement between the Pneumoscope thermometer and reference thermometers (Terumo® C205 and VisioFocus Pro® 06480).
- Agreement between the Pneumoscope pulse oximeter (for blood oxygen saturation and heart rate) and reference oximeters (Masimo Rad-G® and iHealth® Air).
Measured: During procedure, i.e. 20 minutes per patient for both out- and inpatients.
Secondary outcomes (3)
Collect audio records of lung sounds for AI models training and sensor calibration
The collected anonymised audio records of lung sounds will be used in the future to develop and validate AI algorithms for various bronchopulmonary diseases in children (pneumonia, asthma, bronchiolitis), as well as SARS-CoV-2 infections in adults.
Measured: During procedure, i.e. 20 minutes per patient for both out- and inpatients.
Pulse oximetry
The collected pulse oximetry measures will be used to calibrate the oximeter sensor.
Measured: During procedure, i.e. 20 minutes per patient for both out- and inpatients.
Body temperature
The collected, non-invasive, body temperature measures will be used to calibrate the thermometer sensor.
Measured: During procedure, i.e. 20 minutes per patient for both out- and inpatients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start15 Apr 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This single center, open, non-controlled investigation will be conducted at one site; 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.
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pediatric Clinical Research Platform
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor
- Investigators
- Alain Gervaix, Prof, Study director, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373939
- Sponsor's protocol ID
- Pneumoscope study
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * Data types: Deidentified participant data. The final database will be shared on a non-commercial repository following the FAIR data principles. * How to access data: contact the principal investigator Dr Johan N. Siebert at: Johan.Siebert@hcuge.ch * When available: beginning 6 months and ending 10 years following article(s) publication.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study of the Performance and Safety of the Pneumoscope Device in Adults and Children
- ClinicalTrials.gov ID
- NCT06373939
- Acronym / sponsor ID
- Pneumoscope study
- Conditions
- Respiratory Diseases, Pneumonia, Asthma, Cyanotic Heart Disease
- Keywords
- Stethoscopes, Oxygen Saturation, Thermometers, Digital Health, Auscultation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Pediatric Clinical Research PlatformUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single center, open, non-controlled investigation will be conducted at one site; 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.
| Arm | Type | Receives |
|---|---|---|
| Children (>1 year old) and adult patients | Experimental | Device: Digital lung auscultation, Device: Pulse oximetry measurement, Device: Non invasive body temperature measurementPatients with various respiratory conditions, such as asthma or pneumonia, along with healthy individuals, will be targeted to assess the Pneumoscope's performance under clinical conditions. Additionally, patients with lower blood oxygen saturation levels, such as those with cyanotic heart defects like tetralogy of Fallot, will also be included |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital lung auscultationTwo 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. | Device | Children (>1 year old) and adult patients |
| Pulse oximetry measurementAlso: OximetersPulse 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. | Device | Children (>1 year old) and adult patients |
| Non invasive body temperature measurementAlso: ThermometersComparison 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. | Device | Children (>1 year old) and adult patients |
Primary outcome
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).
3 secondary outcomes
Collect audio records of lung sounds for AI models training and sensor calibration
Time frame: During procedure, i.e. 20 minutes per patient for both out- and inpatients.
Pulse oximetry
Time frame: During procedure, i.e. 20 minutes per patient for both out- and inpatients.
Body temperature
Time frame: During procedure, i.e. 20 minutes per patient for both out- and inpatients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Yes. * Data types: Deidentified participant data. The final database will be shared on a non-commercial repository following the FAIR data principles. * How to access data: contact the principal investigator Dr Johan N. Siebert at: Johan.Siebert@hcuge.ch * When available: beginning 6 months and ending 10 years following article(s) publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Gervaix, Prof study director
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital lung auscultation, Pulse oximetry measurement and Non invasive body temperature measurement in people with Respiratory Diseases and Pneumonia, run by Pediatric Clinical Research Platform at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan N Siebert, MD ((0)79 553 40 72 ext. +41, Johan.Siebert@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Pneumoscope's built-in sensors (time frame: During procedure, i.e. 20 minutes per patient for both out- and inpatients.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.