Differentiation of Upper and Lower Respiratory Tract Infections Using Automated Lung Sound Analysis With LungPass Device

This observational study evaluates whether lung sound analysis with LungPass device can be used to differentiate upper and lower respiratory tract infections (URTI and LRTI)

Study Overview

• Status: Suspended
• Conditions: Acute Respiratory Tract Infection
• Intervention / Treatment: Device: Lung auscultation with LungPass device (electronic auscultation)

Detailed Description

This is a prospective observational study comprised patients presenting with acute respiratory tract infection symptoms in primary care settings. Patients will undergo routine clinical examination including lung auscultation with conventional stethoscope and LungPass device. Moreover, symptoms and anamnesis data, result of diagnostic questionnaire from the LungPass App, complete blood count, C-reactive protein, procalcitonin (PCT) level, SARS-CoV-2 PCR test and X-ray chest examination or CT chest (in case of preliminary clinical suspicion of LRTI). Patients will be followed up within 5-7 days and at the end of the disease in person or by phone for clinical course of the disease assessment to confirm the final diagnosis (URTI or LRTI). Final diagnosis will be considered as Gold standard for accuracy assessment.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Belarus
  • Minsk, Belarus, 220114
    • 19th Сentral District Polyclinic of Pervomaisky District of Minsk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants will be recruited in primary care settings upon presentation with symptoms of acute respiratory infection.

It is planned to start recruiting 100 adult patients and 100 children with URTI and 100 adults and 100 children with LRTI. The final calculation of the sample size will be carried out after receiving the preliminary results of the study. After that, the sample size will be adjusted.

Description

Inclusion Criteria:

• Adults (over 18 years) and children (3-18 years) of both sexes;
• Patients able and willing to sign an informed consent to participate in the study (parents of children younger than 18 years old will be allowed to give an informed consent on behalf of their children).
• Patients presenting with a new onset of at least two of listed acute respiratory tract infection symptoms within the last 5 days: cough, purulent sputum, breathlessness, core temperature above 38°C.
• Patients who first visit a GP with these symptoms within the first 5 days from the onset of symptoms and was not previously treated with antibiotics during the last month.

Exclusion Criteria:

• Age up to 3 years;
• Patient refusal to participate in the study (or patients' parents);
• Children under full State care (orphans, children left without parental care);
• Treatment with antibiotics during the last month;
• Patients with subcutaneous emphysema, with damaged skin on the surface of the chest, with drainage in the pleural space, patients undergoing mechanical ventilation;
• Presence of other known chronic lung conditions such as asthma, COPD, tuberculosis, cystic fibrosis or bronchiectasis;
• Mental illness, other known acute diseases or known chronic decompensated diseases, such as a known active malignancy or severe heart failure.
• Other known ongoing infection.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of identifying LRTI by abnormal lung sounds	Accuracy of differentiation between ULRTI and LRTI by abnormal lung sounds detected with LungPass device	16.11.2021- 30.11.2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of identifying LRTI by abnormal lung sounds in subgroups with COVID-19 and non-COVID-19 LRTI	Accuracy of differentiation between ULRTI and LRTI by abnormal lung sounds detected with LungPass device in subgroups with COVID-19 and non-COVID-19 LRTI	16.11.2021- 30.11.2021
Lung sounds and clinical signs of LRTI correlation in patients with LRTI	Correlation between presence of pathological pulmonary sounds detected with LungPass device and presence of clinical signs of LRTI (clinical parameters/radiology results) in patients with LRTI	16.11.2021- 30.11.2021

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of LRTI detection by LungPass App output	Accuracy of of identifying LRTI by LungPass App output which based on abnormal lung sounds detected with LungPass device together with symptoms collected using a questionnaire in the LungPass app*. * Final LungPass App output is possible patient condition (acute respiratory infection, acute bronchitis, pneumonia, etc)	16.11.2021- 30.11.2021
Accuracy of bacterial LRTI detection by abnormal lung sounds using procalcitonin level as Gold Standard	Accuracy of identifying bacterial LRTI by abnormal lung sounds detected with LungPass device using procalcitonin level as Gold Standard	16.11.2021- 30.11.2021

Collaborators and Investigators

• Sponsor: Healthy Networks
• Collaborators: University of Manchester; Belarusian Medical Academy of Post-Graduate Education
• Investigators: Study Director: Helena Binetskaya, CEO

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Lung sound analysis; Upper Respiratory Truct Infections; Lower Respiratory Truct Infections
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Signs and Symptoms, Respiratory; Infections; Communicable Diseases; Respiratory Tract Infections; Respiratory Sounds
• Other Study ID Numbers: № 4-3/YH-2056/LP06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No