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Completed

NCT Number: NCT02598336

Validation of Structured Light Plethysmography

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.

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Key information

Age range

6 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cambridge University Hospitals Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Structured Light Plethysmography

Device

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

Other names: SLP

Pneumotachograph Spirometry

Device

Device that measures airflow at the mouth using a mouthpiece

Primary outcomes

  1. Forced Vital Capacity (FVC) measured in Litres

    Time frame: 5 minutes

    The volume of air a person can exhale during a maximal forced breath

  2. Forced Expiratory Volume in one second (FEV1) measured in litres per second

    Time frame: 5 minutes

    The volume of air a person can exhale in one second during a maximal forced breath

  3. Peak Expiratory Flow (PEF) measured in litres per second

    Time frame: 5 minutes

    The maximal flow a person can achieve during a maximal forced breath

Secondary outcomes

  1. Respiratory Waveform

    Time frame: 5 minutes

    Visual comparison of respiratory waveform shape and amplitude produced by pneumotachograph and SLP.

  2. Respiratory Rate (RR) measured in seconds

    Time frame: 5 minutes

    Tmings derived from the Respiratory Waveforms

  3. Inspiratory Time (tI) measured in seconds

    Time frame: 5 minutes

    Timings derived from the Respiratory Waveforms

  4. Expiratory Time (tE) measured in seconds

    Time frame: 5 minutes

    Timings derived from the Respiratory Waveforms

  5. Total breath time (tTot) measured in seconds

    Time frame: 5 minutes

    Timings derived from the Respiratory Waveforms

  6. Inspiratory/expiratory ratio (tI/tE) expressed as a ratio

    Time frame: 5 minutes

    Timing ratios derived from the Respiratory Waveforms

  7. The duty cycle (tI/tTot) expressed as a ratio

    Time frame: 5 minutes

    Timing ratios derived from the Respiratory Waveforms

Other outcomes

  1. Inspiratory over Expiratory flow at 50 percent of tidal displacement (IE50) expressed at a ratio

    Time frame: 5 minutes

    Flow ratios derived from the Respiratory Waveforms

Sponsors and collaborators

Lead sponsor

Pneumacare Ltd

Industry

Collaborators

  • Cambridge University Hospitals NHS Foundation Trust
  • University of Cambridge

Registry information

Official study title

Validation of Structured Light Plethysmography Against Spirometry in Children and Adults

Acronym: SLPvsPNT

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Nov 5, 2015
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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