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| Name | Class |
|---|---|
| Cambridge University Hospitals NHS Foundation Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A(i) Healthy Volunteers | 50 healthy volunteers. Intervention: Lung sound recording for part A(i) of the study. |
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| Part A(ii) Patients | 100 patients with wheezing and/or crackles due to respiratory disease. Intervention: Lung sound recording for part A(ii) of the study. |
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| Part B(i) 'normal' lung structure | 25 patients who are scheduled to have a Bronchoscopy as part of their standard care and are identified by a medical professional as having a 'normal' lung structure. Intervention: Lung sound transmission measurement for part B(i) of the study. |
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| Part B(ii) 'abnormal' lung structure | 25 patients who are scheduled to have a Bronchoscopy as part of their standard care and are identified by a medical professional as having an 'abnormal' lung structure. Intervention: Lung sound transmission measurement for part B(ii) of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung sound transmission measurement | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Part A(i) 50 healthy volunteers, taken from the general population.
Part A(ii) 100 patients, taken from the population of patients at Addenbrooke's Hospital, Cambridge, UK with clear evidence of wheezing and/or crackles due to respiratory disease. We will aim to recruit approximately 50 patients with wheezing and 50 patients with crackles.
Part B(i) 25 patients, taken from the population of patients on the bronchoscopy list at Addenbrooke's Hospital, Cambridge, UK.
Part B(ii) 25 patients, taken from the population of patients on the bronchoscopy list at Addenbrooke's Hospital, Cambridge, UK
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| Name | Affiliation | Role |
|---|---|---|
| Pasupathy Sivasothy, PhD | Cambridge University Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambridge University Hospitals and the University of Cambridge | Cambridge | United Kingdom |
Non-identifiable patient data will be used in publications and made available on the University of Cambridge's data repository DSpace when the results of the study are published.
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| ID | Term |
|---|---|
| D055091 | Bronchomalacia |
| D001249 | Asthma |
| D008175 | Lung Neoplasms |
| D017563 | Lung Diseases, Interstitial |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D055089 | Tracheobronchomalacia |
| D002357 | Cartilage Diseases |
| D009140 | Musculoskeletal Diseases |
| D001982 | Bronchial Diseases |
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| Lung sound recording | Other | Lung sounds are recorded using a sensor array. |
|
| Will be assessed when all data for Part B of the study has been collected. Up to 30 months. |
| 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. |
| D012140 |
| Respiratory Tract Diseases |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |