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Mapping Sound Propagation Through the Human Lung for Better Diagnosis

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ClinicalTrials.gov Identifier: NCT03043898
Recruitment Status : Terminated (COVID-19)
First Posted : February 6, 2017
Last Update Posted : November 5, 2020
Sponsor:
Collaborator:
Cambridge University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Maximilian Nussbaumer, University of Cambridge

Brief 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.


Condition or disease Intervention/treatment
Bronchomalacia Asthma Lung Neoplasms Lung Diseases, Interstitial Pulmonary Disease, Chronic Obstructive Other: Lung sound transmission measurement Other: Lung sound recording

Detailed 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.

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Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Mapping Sound Propagation Through the Human Lung for Better Diagnosis
Actual Study Start Date : February 14, 2018
Actual Primary Completion Date : April 23, 2020
Actual Study Completion Date : April 23, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Part A(i) Healthy Volunteers
50 healthy volunteers. Intervention: Lung sound recording for part A(i) of the study.
Other: Lung sound recording
Lung sounds are recorded using a sensor array.

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.
Other: Lung sound recording
Lung sounds are recorded using a sensor array.

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.

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.

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.

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.




Primary Outcome Measures :
  1. Comparison of sound propagation through the human chest in subjects with 'normal' and 'abnormal' lung structure. [ Time Frame: Will be assessed when all data for Part B of the study has been collected. Up to 30 months. ]
    This will use a hypothesis test on features extracted from the time-series array data in Part B of the study.


Secondary Outcome Measures :
  1. Database of acoustic response of human chest to a known sound input within the lungs. [ Time Frame: Will be assessed when all data for Part B of the study has been collected. Up to 30 months. ]
    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.

  2. Database of lung sound recordings from array on posterior chest. [ Time Frame: Will be assessed when all data for Part A of the study has been collected. Up to 30 months. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03043898


Locations
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United Kingdom
Cambridge University Hospitals and the University of Cambridge
Cambridge, United Kingdom
Sponsors and Collaborators
Maximilian Nussbaumer
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Pasupathy Sivasothy, PhD Cambridge University Hospitals NHS Foundation Trust
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Responsible Party: Maximilian Nussbaumer, Principal Researcher, University of Cambridge
ClinicalTrials.gov Identifier: NCT03043898    
Other Study ID Numbers: A093684
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Bronchomalacia
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Interstitial
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Tracheobronchomalacia
Cartilage Diseases
Musculoskeletal Diseases
Bronchial Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Connective Tissue Diseases