ClinicalTrials.gov
ClinicalTrials.gov Menu

Chest Wall Motion Analysis in Disease (CWM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02958683
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : February 26, 2018
Sponsor:
Collaborators:
University of Birmingham
University of Warwick
Information provided by (Responsible Party):
Heart of England NHS Trust

Brief Summary:

Breathing movements, called chest wall motion, are very complex. The investigators are studying how movement of the abdomen, ribs and diaphragm contribute to breathing and how this differs with different diseases in the chest. Breathing movements may help with diagnosis, assessment of severity or assessing the impact of treatments for chest conditions. The investigators are following people who have a chest disease, measuring their chest wall motion and comparing it to their diagnosis and and how their treatment works.

Chest wall motion can be measured in different ways at rest and whilst exercising. Small stickers on the chest can be used to reflect infra red light or visible squares of light can be shone onto the chest without using stickers.


Condition or disease Intervention/treatment
Mesothelioma Lung Neoplasms Surgery Cystic Fibrosis Pectus Carinatum Pectus Excavatum Empyema, Pleural Pulmonary Disease, Chronic Obstructive Other: Chest wall motion analysis

Detailed Description:

Optoelectronic plethysmography (OEP) is based on the analysis during breathing of the trajectories of a series of markers positioned on the thoracic-abdominal surface of the patient. The positions in space of these markers are recorded and processed with mathematical models and algorithms by a computing unit that can accurately measure not only volume variations of the whole thoracic-abdominal wall, but also the variations of the various compartments. This detects, for example, asymmetries in the action of respiratory muscles. The system can accurately measure current volume, vital capacity, respiratory frequency, duration of the phases of inspiration and exhalation, the average inspiration and exhalation flux and the volume variations at the end of exhalation.

Structured Light Plethysmography (SLP) also assesses regional chest wall excursion but does not require markers to be placed on the patient. The system uses visible light shone onto the chest wall in a checkerboard pattern and reflected back by the patient's skin or a tight T shirt.

Images from 4 Microsoft Kinnect Motion Cameras can be used to create a 3D representation of the patient's torso. This system has been shown to correlate well with chest wall measurements recorded by OEP.

These systems are innovative examination instruments, non-invasive, accurate, easy to use and unlike traditional plethysmographic technologies, are not affected by humidity and temperature variations and can easily be used to perform measurements for extended periods of time. They accurately measure the dynamics of the volume variations that occur during breathing in the various sections of the thoracic-abdominal walls (upper, lower and abdominal thoracic area). This data, which is otherwise undetectable, is a useful contribution to the evaluation of patients. We will apply chest wall motion analysis to understanding the physiology of thoracic disease processes as well as assessing potential diagnostic and prognostic (response to treatment) markers that could be used in future clinical practice.


Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: An Observational Study of Chest Wall Motion Analysis in Disease
Study Start Date : July 2011
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019


Group/Cohort Intervention/treatment
Pectus excavatum
Patients with pectus excavatum (funnel chest) condition undergo chest wall motion analysis
Other: Chest wall motion analysis
Assessment of chest wall motion using novel technologies including: optoelectronic plethysmography (OEP), structured light plethysmography (SLP), Microsoft Kinnect

Pectus carinatum
Patients with pectus carinatum (pigeon chest) condition undergo chest wall motion analysis
Other: Chest wall motion analysis
Assessment of chest wall motion using novel technologies including: optoelectronic plethysmography (OEP), structured light plethysmography (SLP), Microsoft Kinnect

Chronic obstructive pulmonary disease
Patients affected by COPD undergo chest wall motion analysis
Other: Chest wall motion analysis
Assessment of chest wall motion using novel technologies including: optoelectronic plethysmography (OEP), structured light plethysmography (SLP), Microsoft Kinnect

Diaphragm abnormality
Patients with abnormal function or structure of the diaphragm. Including diaphragmatic hernia/rupture and diaphragmatic paralysis undergo chest wall motion analysis
Other: Chest wall motion analysis
Assessment of chest wall motion using novel technologies including: optoelectronic plethysmography (OEP), structured light plethysmography (SLP), Microsoft Kinnect

Healthy control
People who do not have any diagnosed thoracic condition and who do not have symptoms/signs suggestive of undiagnosed thoracic disease undergo chest wall motion analysis
Other: Chest wall motion analysis
Assessment of chest wall motion using novel technologies including: optoelectronic plethysmography (OEP), structured light plethysmography (SLP), Microsoft Kinnect

Lung cancer
Patients with suspected or confirmed lung malignancy of all histological subtypes undergo chest wall motion analysis
Other: Chest wall motion analysis
Assessment of chest wall motion using novel technologies including: optoelectronic plethysmography (OEP), structured light plethysmography (SLP), Microsoft Kinnect

Pleural disease
Patients with pleural thickening and/or pleural effusion, pneumothorax, empyema undergo chest wall motion analysis
Other: Chest wall motion analysis
Assessment of chest wall motion using novel technologies including: optoelectronic plethysmography (OEP), structured light plethysmography (SLP), Microsoft Kinnect

Asthma
Patients diagnosed with asthma clinically or upon spirometry undergo chest wall motion analysis
Other: Chest wall motion analysis
Assessment of chest wall motion using novel technologies including: optoelectronic plethysmography (OEP), structured light plethysmography (SLP), Microsoft Kinnect

Cystic fibrosis
Patients diagnosed with cystic fibrosis clinically or biochemically undergo chest wall motion analysis
Other: Chest wall motion analysis
Assessment of chest wall motion using novel technologies including: optoelectronic plethysmography (OEP), structured light plethysmography (SLP), Microsoft Kinnect

Rib or sternal disease
Patients with an abnormality in the chest wall including fractures, osteomyelitis, malignancy of all histological subtypes, chest wall resection/reconstruction undergo chest wall motion analysis
Other: Chest wall motion analysis
Assessment of chest wall motion using novel technologies including: optoelectronic plethysmography (OEP), structured light plethysmography (SLP), Microsoft Kinnect




Primary Outcome Measures :
  1. Change in volume of each thoracoabdominal compartment during breathing [ Time Frame: Baseline, follow up after normal clinical care up to 3 times (inpatient after surgery, 4-6 weeks, 3-12 months) ]
    Measured in litres


Secondary Outcome Measures :
  1. Synchrony of chest wall movement [ Time Frame: Baseline, follow up after normal clinical care up to 3 times (inpatient after surgery, 4-6 weeks, 3-12 months) ]
    Measured in degrees



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients or their healthy acquaintances attending Heart of England NHS Foundation trust for care under the thoracic surgery department or respiratory department.
Criteria

Inclusion Criteria:

  • Aged 16 or over
  • Have thoracic disease or healthy control

Exclusion Criteria:

  • Unable to provide valid informed consent

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): NCT02958683


Contacts
Contact: Babu Naidu, MBBS 441214242000 babu.naidu@heartofengland.nhs.uk

Locations
United Kingdom
Heart of England NHS Foundation Trust Recruiting
Birmingham, West Midlands, United Kingdom, B95SS
Contact: Babu Naidu, MBBS    441214242000    babu.naidu@heartofengland.nhs.uk   
Contact: Amy Kerr, MRes    441214242000    amy.kerr@heartofengland.nhs.uk   
Sponsors and Collaborators
Heart of England NHS Trust
University of Birmingham
University of Warwick
Investigators
Principal Investigator: Babu Naidu, MBBS Heart of England NHS Foundation Trust

Additional Information:
SLP  This link exits the ClinicalTrials.gov site

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heart of England NHS Trust
ClinicalTrials.gov Identifier: NCT02958683     History of Changes
Other Study ID Numbers: 2010109TS
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Heart of England NHS Trust:
Optoelectronic plethysmography
Structure light plethysmography
Respiratory Function Tests

Additional relevant MeSH terms:
Lung Diseases
Cystic Fibrosis
Mesothelioma
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Lung Neoplasms
Funnel Chest
Empyema
Pectus Carinatum
Empyema, Pleural
Respiratory Tract Diseases
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities