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

NCT05175612 | Suspended DMC

• 1 other identifier: № 4-3/YH-2056/LP06
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Acute Respiratory Tract Infection

Keywords

Lung sound analysis; Upper Respiratory Truct Infections; Lower Respiratory Truct Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Accuracy of identifying LRTI by abnormal lung sounds 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

  16.11.2021- 30.11.2021

Other Outcomes (2)

• Accuracy of LRTI detection by LungPass App output

  16.11.2021- 30.11.2021

• Accuracy of bacterial LRTI detection by abnormal lung sounds using procalcitonin level as Gold Standard

  16.11.2021- 30.11.2021

Interventions

Lung auscultation with LungPass device (electronic auscultation) DEVICE

Lung auscultation with electronic stethoscope

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Healthy Networks: lead
• Belarusian Medical Academy of Post-Graduate Education: collaborator
• University of Manchester: collaborator

Study Sites (1)

19th Сentral District Polyclinic of Pervomaisky District of Minsk

Minsk, 220114, Belarus

Location

Study Officials

• Helena Binetskaya

  CEO

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: January 4, 2022
• Study Start: November 16, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: June 7, 2022

Record last verified: 2022-06

Locations

BE (1)