NCT02958683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

4.1 years

First QC Date

August 5, 2016

Last Update Submit

February 21, 2019

Conditions

Keywords

Optoelectronic plethysmographyStructure light plethysmographyRespiratory Function Tests

Outcome Measures

Primary Outcomes (1)

  • Change in volume of each thoracoabdominal compartment during breathing

    Measured in litres

    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

    Baseline, follow up after normal clinical care up to 3 times (inpatient after surgery, 4-6 weeks, 3-12 months)

Study Arms (10)

Pectus excavatum

Patients with pectus excavatum (funnel chest) condition 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

Chronic obstructive pulmonary disease

Patients affected by COPD 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

Pleural disease

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

Other: Chest wall motion analysis

Asthma

Patients diagnosed with asthma clinically or upon spirometry 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

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

Interventions

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

AsthmaChronic obstructive pulmonary diseaseCystic fibrosisDiaphragm abnormalityHealthy controlLung cancerPectus carinatumPectus excavatumPleural diseaseRib or sternal disease

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Unable to provide valid informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart of England NHS Foundation Trust

Birmingham, West Midlands, B95SS, United Kingdom

Location

Related Publications (2)

  • Aliverti A, Pedotti A. Opto-electronic plethysmography. Monaldi Arch Chest Dis. 2003 Jan-Mar;59(1):12-6.

    PMID: 14533277BACKGROUND
  • Oswald 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.

MeSH Terms

Conditions

MesotheliomaLung NeoplasmsCystic FibrosisPectus CarinatumFunnel ChestEmpyema, PleuralPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesPancreatic DiseasesDigestive System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesCartilage DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesRespiratory Tract InfectionsInfectionsEmpyemaSuppurationPleural DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveChronic DiseaseDisease Attributes

Study Officials

  • Babu Naidu, MBBS

    Heart of England NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

November 8, 2016

Study Start

July 1, 2011

Primary Completion

July 31, 2015

Study Completion

July 31, 2015

Last Updated

February 22, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations