Mapping Sound Propagation Through the Human Lung for Better Diagnosis

Asthma Clinical Trial

Official title:

Mapping Sound Propagation Through the Human Lung for Better Diagnosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03043898
• Other study ID #: A093684
• Status: Terminated
• Start date: February 14, 2018
• Est. completion date: April 23, 2020

Study information

• Verified date: November 2020
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study investigates the propagation of sound from a source in the chest to the chest wall.

The methodology of the study will be to place a sound source at a known location in the chest and measure the acoustic response on the posterior chest wall with an acoustic sensor array.

The sound source will be created by playing sound down the working channel of a bronchoscope and located anatomically using direct imaging.

Subjects will be selected for the study by asking patients undergoing a bronchoscopy procedure whether they would be willing to take part in the experiment in addition to their standard procedure.

Procedures will take place in the Bronchoscopy Unit at Addenbrooke's hospital in Cambridge. The Unit runs regional speciality clinics in severe chronic obstructive pulmonary disease, asthma, lung cancer, bronchomalacia and interstitial lung disease and has a nationally significant interventional bronchoscopy service.

A subsidiary part of the study (Part A) will collect sound recordings from healthy volunteers and patients with common respiratory diseases using the same acoustic sensor array. This is to create a database of lung sounds and quantify inter-subject variability.

The study will last approximately 30 months.

Description:

The study has two parts, A and B. Both parts are observational studies of the sounds heard at the chest as recorded by an acoustic array.

In Part A, healthy volunteers and patients at Addenbrooke's hospital will have the chest sounds at their back recorded using an electronic-stethoscope array. This will be done in a single session lasting approximately 30 minutes. 50 healthy volunteers and 100 patients will be included.

In Part B, 50 patients undergoing a bronchoscopy at Addenbrooke's hospital will have their bronchoscopy extended by 5-10 minutes so that sounds can be played through the working channel of the bronchoscope and recorded by a microphone array at the posterior chest. Part B will investigate 25 patients with structurally 'normal' lungs (for example patients with Chronic Cough) (Part B(i)), and 25 patients with lung disease that has resulted in an 'abnormal' lung structure (Part B(ii)).

The consultant bronchoscopist will assign the patient to the relevant group based on information from their medical history and their CT scan. For Part B of the study an existing CT scan is an inclusion criterion. CT scans will not be carried out specifically for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: April 23, 2020
• Est. primary completion date: April 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study.

• Male of Female, aged 18 years or above.

• Part A(i) Healthy volunteer with no history of smoking, recreational drug use or respiratory disease.

• Part A(ii) Patient admitted to Addenbrooke's with a pulmonary disease resulting in crackles and/or wheezes (as diagnosed by a qualified medical practitioner).

• Part B Patient admitted to Addenbrooke's hospital for a bronchoscopy procedure.

• Part B Appropriate recent imaging available: chest CT within 3 months.

• Part B(i) Lung structure deemed 'normal' by pulmonary physician based on CT scan and medical history.

• Part B(i) Lung structure deemed 'abnormal' by pulmonary physician based on CT scan and medical history.

Exclusion Criteria:

• Informed consent is not given.

• Subject is under 18 years old.

• WHO performance status >2.

• Subject is pregnant.

• Subject is unable to understand English.

• Part A(i) History of smoking, recreational drug use or respiratory disease.

• Part A(ii) Condition judged to have no effect on breathing sounds. Patient with crackle or wheeze when quota for crackle or wheeze patients respectively is fulfilled.

• Part B Risk associated with prolonging bronchoscopy procedure judged to be too high by medical professional.

• Part B Appropriate recent imaging (chest CT within 3 months) not available.

Related Conditions & MeSH terms

• Asthma
• Bronchomalacia
• Lung Diseases
• Lung Diseases, Interstitial
• Lung Neoplasms
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Lung sound transmission measurement
Sound at chest wall is recorded using a sensor array during the bronchoscopy procedure, while a sound is played down the working channel of the bronchoscope.
• Lung sound recording
Lung sounds are recorded using a sensor array.

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals and the University of Cambridge	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
Maximilian Nussbaumer	Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of sound propagation through the human chest in subjects with 'normal' and 'abnormal' lung structure.	This will use a hypothesis test on features extracted from the time-series array data in Part B of the study.	Will be assessed when all data for Part B of the study has been collected. Up to 30 months.
Secondary	Database of acoustic response of human chest to a known sound input within the lungs.	This will consist of acoustic data from an array of acoustic sensors on the posterior back, acoustic data from the sound source, photographs of the back with sensor locations and key anatomical features marked and thorax CT scans. This database will be used to investigate propagation mechanisms and localisation techniques.	Will be assessed when all data for Part B of the study has been collected. Up to 30 months.
Secondary	Database of lung sound recordings from array on posterior chest.	This will consist of acoustic data from an array of acoustic sensors at the posterior chest of supine participants taken while these perform a series of breathing exercises. The database will also include basic biometric data.	Will be assessed when all data for Part A of the study has been collected. Up to 30 months.