Validation of Structured Light Plethysmography

NCT ID: NCT02598336

Last Updated: 2018-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2017-09-30

Brief Summary

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Measurements of Structured Light Plethysmography (SLP) using a chest wall movement based method will be compared to those obtained by spirometry using a flow based pneumotachograph method. This study will enable validation of SLP in children and adults by allowing direct comparison of simultaneous measurements of breathing sequences using the two measurement techniques.

The investigators will also examine, in a group of normal adults, repeatability of the agreement between the two devices, and whether the agreement is affected by a change in tidal breathing parameters.

Detailed Description

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Measurements using the Structured Light Plethysmography method will be compared to those obtained by spirometry using a flow based pneumotachograph.

Spirometry is the gold standard for measuring lung function in both clinical support and research roles. Modern spirometers are high precision, reliable instruments enabling a large numbers of parameters relating to lung volumes and the rate of emptying the lungs during a forced expiration to be measured. The most common and accurate method to measure the patient's forced expiration is via pneumotachograph which measures the flow of air through a mouthpiece and integrates the signal to derive the volume expired.

Structured Light Plethysmography (SLP) system that measures changes of the chest and abdominal wall movement during breathing by modelling the thorax and abdominal surface defined by a projected structured light pattern which enables a grid of virtual parts to be formed, the movement of which is recorded by digital cameras. SLP provides non-contact assessment to provide lung function data utilising structured light technologies and enhanced imaging processing.

In this study direct comparison will be made of measurements recorded simultaneously using the two measuring devices in children and adults.

To examine repeatability of the agreement between tidal breathing parameters measured by two techniques, repeated measurements will be performed in each of a group of normal adult subjects. The investigators will also examine whether the agreement is affected by a change in tidal breathing parameters. To obtain a change in tidal breathing parameters, measurements will be recorded during resting spontaneous breathing and after a period of exercise to elevate Respiratory Rate.

Conditions

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Pulmonary Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Breathing Sequence

Simultaneous measurement using Structured Light Plethysmography and Pneumotachograph Spirometry during a period of tidal breathing followed by a forced respiratory manoeuvre. This sequence is repeated twice.

Group Type OTHER

Structured Light Plethysmography

Intervention Type DEVICE

Non contact device that uses light to record displacement of the anterior thorax and abdomen region

Pneumotachograph Spirometry

Intervention Type DEVICE

Device that measures airflow at the mouth using a mouthpiece

Agreement and repeatability Breathing Sequence

Simultaneous measurement using Structured Light Plethysmography and Pneumotachograph Spirometry during a period of tidal breathing. This sequence is repeated one further time at rest, and once further time after an exercise test to elevate respiratory rate.

Group Type OTHER

Structured Light Plethysmography

Intervention Type DEVICE

Non contact device that uses light to record displacement of the anterior thorax and abdomen region

Pneumotachograph Spirometry

Intervention Type DEVICE

Device that measures airflow at the mouth using a mouthpiece

Interventions

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Structured Light Plethysmography

Non contact device that uses light to record displacement of the anterior thorax and abdomen region

Intervention Type DEVICE

Pneumotachograph Spirometry

Device that measures airflow at the mouth using a mouthpiece

Intervention Type DEVICE

Other Intervention Names

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SLP

Eligibility Criteria

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Inclusion Criteria

* For the patient group, any patient attending the outpatient department or the Lung Function Laboratory
* For the Healthy Normals group, any adult between 18 and 80 years with no current or previous respiratory condition.

Exclusion Criteria

* A current cold or other viral infection
* chest surgery within 4 weeks
* Haemoptysis of unknown origin the (forced expiratory manoeuvre may aggravate the underlying condition)
* Pneumothorax
* Unstable respiratory or cardiovascular status (forced expiratory manoeuvre may worsen angina or cause changes in blood pressure) or recent myocardial infarction or pulmonary embolus
* Recent eye surgery
* Presence of an acute disease process that might interfere with test performance (e.g. Nausea, vomiting)
Minimum Eligible Age

6 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Cambridge

OTHER

Sponsor Role collaborator

Pneumacare Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karl Sylvester, PhD

Role: PRINCIPAL_INVESTIGATOR

Addenbrookes University Hospitals NHS Trust

Locations

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Cambridge University Hospitals Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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Stocks J, Godfrey S, Beardsmore C, Bar-Yishay E, Castile R; ERS/ATS Task Force on Standards for Infant Respiratory Function Testing. European Respiratory Society/American Thoracic Society. Plethysmographic measurements of lung volume and airway resistance. ERS/ATS Task Force on Standards for Infant Respiratory Function Testing. European Respiratory Society/ American Thoracic Society. Eur Respir J. 2001 Feb;17(2):302-12. doi: 10.1183/09031936.01.17203020.

Reference Type BACKGROUND
PMID: 11334135 (View on PubMed)

Bates JH, Schmalisch G, Filbrun D, Stocks J. Tidal breath analysis for infant pulmonary function testing. ERS/ATS Task Force on Standards for Infant Respiratory Function Testing. European Respiratory Society/American Thoracic Society. Eur Respir J. 2000 Dec;16(6):1180-92. doi: 10.1034/j.1399-3003.2000.16f26.x.

Reference Type BACKGROUND
PMID: 11292125 (View on PubMed)

Ferrigno G, Carnevali P, Aliverti A, Molteni F, Beulcke G, Pedotti A. Three-dimensional optical analysis of chest wall motion. J Appl Physiol (1985). 1994 Sep;77(3):1224-31. doi: 10.1152/jappl.1994.77.3.1224.

Reference Type BACKGROUND
PMID: 7836125 (View on PubMed)

Cala SJ, Kenyon CM, Ferrigno G, Carnevali P, Aliverti A, Pedotti A, Macklem PT, Rochester DF. Chest wall and lung volume estimation by optical reflectance motion analysis. J Appl Physiol (1985). 1996 Dec;81(6):2680-9. doi: 10.1152/jappl.1996.81.6.2680.

Reference Type BACKGROUND
PMID: 9018522 (View on PubMed)

Other Identifiers

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CIP01/0010

Identifier Type: -

Identifier Source: org_study_id

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