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

Acute Respiratory Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05175612
• Other study ID #: ? 4-3/YH-2056/LP06
• Status: Suspended
• Start date: November 16, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: June 2022
• Source: Healthy Networks
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 400
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Tract Infection
• Communicable Diseases
• Infections
• Respiratory Sounds
• Respiratory Tract Infections

Intervention

Device:
• Lung auscultation with LungPass device (electronic auscultation)
Lung auscultation with electronic stethoscope

Locations

Country	Name	City	State
Belarus	19th ?entral District Polyclinic of Pervomaisky District of Minsk	Minsk

Sponsors (3)

Lead Sponsor	Collaborator
Healthy Networks	Belarusian Medical Academy of Post-Graduate Education, University of Manchester

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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