Clinical trial NCT02598336: Validation of Structured Light Plethysmography
Official title: Validation of Structured Light Plethysmography Against Spirometry in Children and Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Keywords: Structured Light Plethysmography
Spirometry
Pneumotachograph
Lead sponsor: Pneumacare Ltd
Sponsor class: INDUSTRY
Collaborators: name: Cambridge University Hospitals NHS Foundation Trust
name: University of Cambridge
First posted: 2015-11-05
Enrollment: 41
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Forced Vital Capacity (FVC) measured in Litres
timeFrame: 5 minutes
measure: Forced Expiratory Volume in one second (FEV1) measured in litres per second
timeFrame: 5 minutes
measure: Peak Expiratory Flow (PEF) measured in litres per second
timeFrame: 5 minutes
Secondary outcomes:
measure: Respiratory Waveform
timeFrame: 5 minutes
measure: Respiratory Rate (RR) measured in seconds
timeFrame: 5 minutes
measure: Inspiratory Time (tI) measured in seconds
timeFrame: 5 minutes
measure: Expiratory Time (tE) measured in seconds
timeFrame: 5 minutes
measure: Total breath time (tTot) measured in seconds
timeFrame: 5 minutes
measure: Inspiratory/expiratory ratio (tI/tE) expressed as a ratio
timeFrame: 5 minutes
measure: The duty cycle (tI/tTot) expressed as a ratio
timeFrame: 5 minutes
Other outcomes:
measure: Inspiratory over Expiratory flow at 50 percent of tidal displacement (IE50) expressed at a ratio
timeFrame: 5 minutes
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals Foundation Trust
state: Cambridgeshire
Study officials:
affiliation: Addenbrookes University Hospitals NHS Trust
name: Karl Sylvester, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.