Chest Wall Motion Analysis in Disease

ID: NCT02958683
Status: Recruiting
Phase: N/A
Start Date: July 01, 2011
First Submitted: August 05, 2016
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: Heart of England NHS Trust, University of Birmingham, University of Warwick
Location: United Kingdom
Conditions: Mesothelioma, Lung Neoplasms, Surgery, Cystic Fibrosis, Pectus Carinatum, Pectus Excavatum, Empyema, Pleural, Pulmonary Disease, Chronic Obstructive
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Study Description

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.

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.
Condition or disease Intervention/treatment Phase

Cystic Fibrosis

Empyema, Pleural

Lung Neoplasms

Mesothelioma

Pectus Carinatum

Pectus Excavatum

Pulmonary Disease, Chronic Obstructive

Surgery

Other: Chest wall motion analysis
Other Names
N/A

Tracking Information

First Submitted DateAugust 05, 2016
Last Update Posted DateFebruary 23, 2018
Start DateJuly 01, 2011
Anticipated Completion DateJuly 01, 2019
Primary Completion DateJuly 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleChest Wall Motion Analysis in Disease
Official TitleAn Observational Study of Chest Wall Motion Analysis in Disease
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.

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 TypeObservational
Study PhaseN/A
Estimated Enrollment
400
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Cystic Fibrosis
Empyema, Pleural
Lung Neoplasms
Mesothelioma
Pectus Carinatum
Pectus Excavatum
Pulmonary Disease, Chronic Obstructive
Surgery
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationAdult patients or their healthy acquaintances attending Heart of England NHS Foundation trust for care under the thoracic surgery department or respiratory department.
Intervention
Other: Chest wall motion analysis

Assessment of chest wall motion using novel technologies including: optoelectronic plethysmography (OEP), structured light plethysmography (SLP), Microsoft Kinnect

Other Names
Study Groups/Cohorts
Pectus excavatum
Patients with pectus excavatum (funnel chest) condition undergo chest wall motion analysis

Pectus carinatum
Patients with pectus carinatum (pigeon chest) condition undergo chest wall motion analysis

Chronic obstructive pulmonary disease
Patients affected by COPD undergo chest wall motion analysis

Diaphragm abnormality
Patients with abnormal function or structure of the diaphragm. Including diaphragmatic hernia/rupture and diaphragmatic paralysis undergo chest wall motion analysis

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

Lung cancer
Patients with suspected or confirmed lung malignancy of all histological subtypes undergo chest wall motion analysis

Pleural disease
Patients with pleural thickening and/or pleural effusion, pneumothorax, empyema undergo chest wall motion analysis

Asthma
Patients diagnosed with asthma clinically or upon spirometry undergo chest wall motion analysis

Cystic fibrosis
Patients diagnosed with cystic fibrosis clinically or biochemically undergo chest wall motion analysis

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

Study Arms
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

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

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

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

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

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

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

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

Arm Intervention/Treatment
Asthma
Patients diagnosed with asthma clinically or upon spirometry undergo chest wall motion analysis
Other : Chest wall motion analysis
Chronic obstructive pulmonary disease
Patients affected by COPD undergo chest wall motion analysis
Other : Chest wall motion analysis
Cystic fibrosis
Patients diagnosed with cystic fibrosis clinically or biochemically undergo chest wall motion analysis
Other : Chest wall motion analysis
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
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
Lung cancer
Patients with suspected or confirmed lung malignancy of all histological subtypes undergo chest wall motion analysis
Other : Chest wall motion analysis
Pectus carinatum
Patients with pectus carinatum (pigeon chest) condition undergo chest wall motion analysis
Other : Chest wall motion analysis
Pectus excavatum
Patients with pectus excavatum (funnel chest) condition undergo chest wall motion analysis
Other : Chest wall motion analysis
Pleural disease
Patients with pleural thickening and/or pleural effusion, pneumothorax, empyema undergo chest wall motion analysis
Other : Chest wall motion analysis
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

Recruitment Information

Recruitment Status:Recruiting
Enrollment400
Completion DateJuly 01, 2019
Eligibility Criteria: Inclusion Criteria:
- Aged 16 or over
- Have thoracic disease or healthy control

Exclusion Criteria:
- Unable to provide valid informed consent
GenderAll
Age16 Years to N/A
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Listed Location Countries
United Kingdom

Administrative Information

NCT Number:NCT02958683
Other Study ID Numbers
2010109TS
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Heart of England NHS Trust
Collaborators
University of Birmingham
University of Warwick
Investigators
Principal Investigator
Babu Naidu, MBBS
Heart of England NHS Foundation Trust