Mapping Sound Propagation Through the Human Lung for Better Diagnosis

NCT03043898 | Terminated

• 1 other identifier: A093684
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Database of acoustic response of human chest to a known sound input within the lungs.

  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.

  Will be assessed when all data for Part A of the study has been collected. Up to 30 months.

Study Arms (4)

Part A(i) Healthy Volunteers

50 healthy volunteers. Intervention: Lung sound recording for part A(i) of the study.

Other: Lung sound recording

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

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

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

Interventions

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.

Part B(i) 'normal' lung structure; Part B(ii) 'abnormal' lung structure

Lung sound recording OTHER

Lung sounds are recorded using a sensor array.

Part A(i) Healthy Volunteers; Part A(ii) Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maximilian Nussbaumer: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Cambridge University Hospitals and the University of Cambridge

Cambridge, United Kingdom

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Tracheobronchomalacia; Cartilage Diseases; Musculoskeletal Diseases; Bronchial Diseases; Respiratory Tract Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pasupathy Sivasothy, PhD

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Researcher

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 6, 2017
• Study Start: February 14, 2018
• Primary Completion: April 23, 2020
• Study Completion: April 23, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)