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Validation of Structured Light Plethysmography (SLPvsPNT)

Primary Purpose

Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Structured Light Plethysmography
Pneumotachograph Spirometry
Sponsored by
Pneumacare Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Disease focused on measuring Structured Light Plethysmography, Spirometry, Pneumotachograph

Eligibility Criteria

6 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Cambridge University Hospitals Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Breathing Sequence

Agreement and repeatability Breathing Sequence

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Forced Vital Capacity (FVC) measured in Litres
The volume of air a person can exhale during a maximal forced breath
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
Peak Expiratory Flow (PEF) measured in litres per second
The maximal flow a person can achieve during a maximal forced breath

Secondary Outcome Measures

Respiratory Waveform
Visual comparison of respiratory waveform shape and amplitude produced by pneumotachograph and SLP.
Respiratory Rate (RR) measured in seconds
Tmings derived from the Respiratory Waveforms
Inspiratory Time (tI) measured in seconds
Timings derived from the Respiratory Waveforms
Expiratory Time (tE) measured in seconds
Timings derived from the Respiratory Waveforms
Total breath time (tTot) measured in seconds
Timings derived from the Respiratory Waveforms
Inspiratory/expiratory ratio (tI/tE) expressed as a ratio
Timing ratios derived from the Respiratory Waveforms
The duty cycle (tI/tTot) expressed as a ratio
Timing ratios derived from the Respiratory Waveforms

Full Information

First Posted
November 3, 2015
Last Updated
July 7, 2018
Sponsor
Pneumacare Ltd
Collaborators
Cambridge University Hospitals NHS Foundation Trust, University of Cambridge
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1. Study Identification

Unique Protocol Identification Number
NCT02598336
Brief Title
Validation of Structured Light Plethysmography
Acronym
SLPvsPNT
Official Title
Validation of Structured Light Plethysmography Against Spirometry in Children and Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2011 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pneumacare Ltd
Collaborators
Cambridge University Hospitals NHS Foundation Trust, University of Cambridge

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease
Keywords
Structured Light Plethysmography, Spirometry, Pneumotachograph

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breathing Sequence
Arm Type
Other
Arm Description
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.
Arm Title
Agreement and repeatability Breathing Sequence
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Structured Light Plethysmography
Other Intervention Name(s)
SLP
Intervention Description
Non contact device that uses light to record displacement of the anterior thorax and abdomen region
Intervention Type
Device
Intervention Name(s)
Pneumotachograph Spirometry
Intervention Description
Device that measures airflow at the mouth using a mouthpiece
Primary Outcome Measure Information:
Title
Forced Vital Capacity (FVC) measured in Litres
Description
The volume of air a person can exhale during a maximal forced breath
Time Frame
5 minutes
Title
Forced Expiratory Volume in one second (FEV1) measured in litres per second
Description
The volume of air a person can exhale in one second during a maximal forced breath
Time Frame
5 minutes
Title
Peak Expiratory Flow (PEF) measured in litres per second
Description
The maximal flow a person can achieve during a maximal forced breath
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Respiratory Waveform
Description
Visual comparison of respiratory waveform shape and amplitude produced by pneumotachograph and SLP.
Time Frame
5 minutes
Title
Respiratory Rate (RR) measured in seconds
Description
Tmings derived from the Respiratory Waveforms
Time Frame
5 minutes
Title
Inspiratory Time (tI) measured in seconds
Description
Timings derived from the Respiratory Waveforms
Time Frame
5 minutes
Title
Expiratory Time (tE) measured in seconds
Description
Timings derived from the Respiratory Waveforms
Time Frame
5 minutes
Title
Total breath time (tTot) measured in seconds
Description
Timings derived from the Respiratory Waveforms
Time Frame
5 minutes
Title
Inspiratory/expiratory ratio (tI/tE) expressed as a ratio
Description
Timing ratios derived from the Respiratory Waveforms
Time Frame
5 minutes
Title
The duty cycle (tI/tTot) expressed as a ratio
Description
Timing ratios derived from the Respiratory Waveforms
Time Frame
5 minutes
Other Pre-specified Outcome Measures:
Title
Inspiratory over Expiratory flow at 50 percent of tidal displacement (IE50) expressed at a ratio
Description
Flow ratios derived from the Respiratory Waveforms
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Sylvester, PhD
Organizational Affiliation
Addenbrookes University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge University Hospitals Foundation Trust
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
11334135
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.
Results Reference
background
PubMed Identifier
11292125
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.
Results Reference
background
PubMed Identifier
7836125
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.
Results Reference
background
PubMed Identifier
9018522
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.
Results Reference
background

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Validation of Structured Light Plethysmography

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