Validation of Structured Light Plethysmography

Pulmonary Disease Clinical Trial

— SLPvsPNT  

Official title:

Validation of Structured Light Plethysmography Against Spirometry in Children and Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598336
• Other study ID #: CIP01/0010
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: September 2017

Study information

• Verified date: July 2018
• Source: Pneumacare Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease

Intervention

Device:
• Structured Light Plethysmography
Non contact device that uses light to record displacement of the anterior thorax and abdomen region
• Pneumotachograph Spirometry
Device that measures airflow at the mouth using a mouthpiece

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals Foundation Trust	Cambridge	Cambridgeshire

Sponsors (3)

Lead Sponsor	Collaborator
Pneumacare Ltd	Cambridge University Hospitals NHS Foundation Trust, University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inspiratory over Expiratory flow at 50 percent of tidal displacement (IE50) expressed at a ratio	Flow ratios derived from the Respiratory Waveforms	5 minutes
Primary	Forced Vital Capacity (FVC) measured in Litres	The volume of air a person can exhale during a maximal forced breath	5 minutes
Primary	Forced Expiratory Volume in one second (FEV1) measured in litres per second	The volume of air a person can exhale in one second during a maximal forced breath	5 minutes
Primary	Peak Expiratory Flow (PEF) measured in litres per second	The maximal flow a person can achieve during a maximal forced breath	5 minutes
Secondary	Respiratory Waveform	Visual comparison of respiratory waveform shape and amplitude produced by pneumotachograph and SLP.	5 minutes
Secondary	Respiratory Rate (RR) measured in seconds	Tmings derived from the Respiratory Waveforms	5 minutes
Secondary	Inspiratory Time (tI) measured in seconds	Timings derived from the Respiratory Waveforms	5 minutes
Secondary	Expiratory Time (tE) measured in seconds	Timings derived from the Respiratory Waveforms	5 minutes
Secondary	Total breath time (tTot) measured in seconds	Timings derived from the Respiratory Waveforms	5 minutes
Secondary	Inspiratory/expiratory ratio (tI/tE) expressed as a ratio	Timing ratios derived from the Respiratory Waveforms	5 minutes
Secondary	The duty cycle (tI/tTot) expressed as a ratio	Timing ratios derived from the Respiratory Waveforms	5 minutes