MesotheliomaCWMNCT02958683
Chest Wall Motion Analysis in Disease
An observational study of Mesothelioma and Lung Neoplasms, run by Heart of England NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mesothelioma, Lung Neoplasms, Surgery
- What is being tested?
- Chest wall motion analysis
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to 31 Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Aged 16 or over
- Have thoracic disease or healthy control
Who cannot join
- Unable to provide valid informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Heart of England NHS Foundation Trust
Birmingham, West Midlands, B95SS
About this study
Official title: An Observational Study of Chest Wall Motion Analysis in Disease
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.
Read the 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.
- Conditions
- Mesothelioma, Lung Neoplasms, Surgery, Cystic Fibrosis, Pectus Carinatum, Pectus Excavatum
- Being tested
- Chest wall motion analysis
- Keywords
- Optoelectronic plethysmography, Structure light plethysmography, Respiratory Function Tests
- Medical subject headings
- Mesothelioma, Lung Neoplasms, Cystic Fibrosis, Pectus Carinatum, Funnel Chest, Empyema, Pleural, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest wall motion analysisOther
Assessment of chest wall motion using novel technologies including: optoelectronic plethysmography (OEP), structured light plethysmography (SLP), Microsoft Kinnect
| Study group | Role | What they receive |
|---|---|---|
| Pectus excavatum | Patients with pectus excavatum (funnel chest) condition undergo chest wall motion analysis Receives: Other: Chest wall motion analysis | |
| Pectus carinatum | Patients with pectus carinatum (pigeon chest) condition undergo chest wall motion analysis Receives: Other: Chest wall motion analysis | |
| Chronic obstructive pulmonary disease | Patients affected by COPD undergo chest wall motion analysis Receives: 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 Receives: 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 Receives: Other: Chest wall motion analysis | |
| Lung cancer | Patients with suspected or confirmed lung malignancy of all histological subtypes undergo chest wall motion analysis Receives: Other: Chest wall motion analysis | |
| Pleural disease | Patients with pleural thickening and/or pleural effusion, pneumothorax, empyema undergo chest wall motion analysis Receives: Other: Chest wall motion analysis | |
| Asthma | Patients diagnosed with asthma clinically or upon spirometry undergo chest wall motion analysis Receives: Other: Chest wall motion analysis | |
| Cystic fibrosis | Patients diagnosed with cystic fibrosis clinically or biochemically undergo chest wall motion analysis Receives: 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 Receives: Other: Chest wall motion analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in volume of each thoracoabdominal compartment during breathing
Measured in litres
Measured: Baseline, follow up after normal clinical care up to 3 times (inpatient after surgery, 4-6 weeks, 3-12 months)
Secondary outcomes (1)
Synchrony of chest wall movement
Measured in degrees
Measured: Baseline, follow up after normal clinical care up to 3 times (inpatient after surgery, 4-6 weeks, 3-12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startJul 2011
- Primary completion31 Jul 2015
- Study completion31 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart of England NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham, University of Warwick
- Responsible party
- Sponsor
- Investigators
- Babu Naidu, MBBS, Principal investigator, Heart of England NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958683
- Sponsor's protocol ID
- 2010109TS
- Acronym
- CWM
- Status last verified
- Feb 2019
- First submitted
- 5 Aug 2016
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Aliverti A, Pedotti A. Opto-electronic plethysmography. Monaldi Arch Chest Dis. 2003 Jan-Mar;59(1):12-6.
PubMed 14533277Oswald N, Jalal Z, Kadiri S, Naidu B. Changes in chest wall motion with removal of Nuss bar in repaired pectus excavatum - a cohort study. J Cardiothorac Surg. 2019 Jan 8;14(1):4. doi: 10.1186/s13019-018-0827-1.
PubMed 30621729
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Chest Wall Motion Analysis in Disease
- ClinicalTrials.gov ID
- NCT02958683
- Acronym / sponsor ID
- CWM / 2010109TS
- Conditions
- Mesothelioma, Lung Neoplasms, Surgery, Cystic Fibrosis, Pectus Carinatum, Pectus Excavatum
- Keywords
- Optoelectronic plethysmography, Structure light plethysmography, Respiratory Function Tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Heart of England NHS TrustUniversity, hospital or other
- Collaborators
- University of Birmingham, University of Warwick
- Study start
- Jul 2011 (actual)
- Primary completion
- 31 Jul 2015 (actual)
- Study completion
- 31 Jul 2015 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Pectus excavatum | – | Other: Chest wall motion analysisPatients with pectus excavatum (funnel chest) condition undergo chest wall motion analysis |
| Pectus carinatum | – | Other: Chest wall motion analysisPatients with pectus carinatum (pigeon chest) condition undergo chest wall motion analysis |
| Chronic obstructive pulmonary disease | – | Other: Chest wall motion analysisPatients affected by COPD undergo chest wall motion analysis |
| Diaphragm abnormality | – | Other: Chest wall motion analysisPatients with abnormal function or structure of the diaphragm. Including diaphragmatic hernia/rupture and diaphragmatic paralysis undergo chest wall motion analysis |
| Healthy control | – | Other: Chest wall motion analysisPeople 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 | – | Other: Chest wall motion analysisPatients with suspected or confirmed lung malignancy of all histological subtypes undergo chest wall motion analysis |
| Pleural disease | – | Other: Chest wall motion analysisPatients with pleural thickening and/or pleural effusion, pneumothorax, empyema undergo chest wall motion analysis |
| Asthma | – | Other: Chest wall motion analysisPatients diagnosed with asthma clinically or upon spirometry undergo chest wall motion analysis |
| Cystic fibrosis | – | Other: Chest wall motion analysisPatients diagnosed with cystic fibrosis clinically or biochemically undergo chest wall motion analysis |
| Rib or sternal disease | – | Other: Chest wall motion analysisPatients with an abnormality in the chest wall including fractures, osteomyelitis, malignancy of all histological subtypes, chest wall resection/reconstruction undergo chest wall motion analysis |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Aged 16 or over
- Have thoracic disease or healthy control
Key exclusion criteria (1 listed)
- Unable to provide valid informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest wall motion analysisAssessment of chest wall motion using novel technologies including: optoelectronic plethysmography (OEP), structured light plethysmography (SLP), Microsoft Kinnect | Other | Asthma, Chronic obstructive pulmonary disease, Cystic fibrosis, Diaphragm abnormality, Healthy control, Lung cancer, Pectus carinatum, Pectus excavatum, Pleural disease, Rib or sternal disease |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Background: PubMed 14533277Aliverti A, Pedotti A. Opto-electronic plethysmography. Monaldi Arch Chest Dis. 2003 Jan-Mar;59(1):12-6.
- Derived from this study: PubMed 30621729Oswald N, Jalal Z, Kadiri S, Naidu B. Changes in chest wall motion with removal of Nuss bar in repaired pectus excavatum - a cohort study. J Cardiothorac Surg. 2019 Jan 8;14(1):4. doi: 10.1186/s13019-018-0827-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babu Naidu, MBBS principal investigator
Heart of England NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mesothelioma and Lung Neoplasms, run by Heart of England NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02958683, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.