Clinical trial NCT05175612: Differentiation of Upper and Lower Respiratory Tract Infections Using Automated Lung Sound Analysis With LungPass Device
Official title: Differentiation of Upper and Lower Respiratory Tract Infections Using Automated Lung Sound Analysis With LungPass Device
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Acute Respiratory Tract Infection
Keywords: Lung sound analysis
Upper Respiratory Truct Infections
Lower Respiratory Truct Infections
Lead sponsor: Healthy Networks
Sponsor class: INDUSTRY
Collaborators: name: Belarusian Medical Academy of Post-Graduate Education
name: University of Manchester
First posted: 2022-01-04
Enrollment: 400
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of identifying LRTI by abnormal lung sounds
timeFrame: 16.11.2021- 30.11.2021
Secondary outcomes:
measure: Accuracy of identifying LRTI by abnormal lung sounds in subgroups with COVID-19 and non-COVID-19 LRTI
timeFrame: 16.11.2021- 30.11.2021
measure: Lung sounds and clinical signs of LRTI correlation in patients with LRTI
timeFrame: 16.11.2021- 30.11.2021
Other outcomes:
measure: Accuracy of LRTI detection by LungPass App output
timeFrame: 16.11.2021- 30.11.2021
measure: Accuracy of bacterial LRTI detection by abnormal lung sounds using procalcitonin level as Gold Standard
timeFrame: 16.11.2021- 30.11.2021
Locations:
city: Minsk
country: Belarus
facility: 19th Сentral District Polyclinic of Pervomaisky District of Minsk
Study officials:
affiliation: CEO
name: Helena Binetskaya
role: STUDY_DIRECTOR
References: