Performance and Safety of the Pneumoscope Device in Adults and Children

NCT06373939 | Recruiting DMC

• 1 other identifier: Pneumoscope study
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Diseases; Pneumonia; Asthma; Cyanotic Heart Disease

Keywords

Stethoscopes; Oxygen Saturation; Thermometers; Digital Health; Auscultation

Outcome Measures

Primary Outcomes (1)

• 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: 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).

  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

  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.

• Body temperature

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

Study Arms (1)

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

Device: Digital lung auscultation; Device: Pulse oximetry measurement; Device: Non invasive body temperature measurement

Interventions

Digital lung auscultation DEVICE

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.

Children (>1 year old) and adult patients

Pulse oximetry measurement DEVICE

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.

Also known as: Oximeters

Children (>1 year old) and adult patients

Non invasive body temperature measurement DEVICE

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.

Also known as: Thermometers

Children (>1 year old) and adult patients

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pediatric Clinical Research Platform: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

Geneva University Hospitals

Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Diseases; Pneumonia; Asthma

Interventions

Thermometers

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Alain Gervaix, Prof

  University Hospital, Geneva

  STUDY DIRECTOR

Central Study Contacts

Johan N Siebert, MD

CONTACT

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

Alain Gervaix, Prof

CONTACT

(0)22 372 45 55; Alain.Gervaix@hcuge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 18, 2024
• Study Start: April 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months and ending 10 years following article(s) publication
• Access Criteria: * Who can access the data: Data will be made available to qualified external researchers whose proposed use of the data has been approved by their Institutional Review Board. * Types of analyses: Data will be made available for a specified research purpose. * Mechanisms of data availability: Data will be made available upon approval of a proposal and with a signed data access agreement. * Any additional restrictions: The request proposal must include a statistician.

Locations

CH (1)