Pulmonary DiseaseSLPvsPNTNCT02598336
Validation of Structured Light Plethysmography
A study testing Structured Light Plethysmography and Pneumotachograph Spirometry in people with Pulmonary Disease, run by Pneumacare Ltd at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 6 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- Structured Light Plethysmography and Pneumotachograph Spirometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: Validation of Structured Light Plethysmography Against Spirometry in Children and Adults
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.
Read the 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.
- Conditions
- Pulmonary Disease
- Being tested
- Structured Light Plethysmography, Pneumotachograph Spirometry
- Keywords
- Structured Light Plethysmography, Spirometry, Pneumotachograph
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Light PlethysmographyDevice
Also called SLP
Non contact device that uses light to record displacement of the anterior thorax and abdomen region
Pneumotachograph SpirometryDevice
Device that measures airflow at the mouth using a mouthpiece
| Study group | Role | What they receive |
|---|---|---|
| Breathing Sequence | Other | 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. Receives: Device: Structured Light Plethysmography; Device: Pneumotachograph Spirometry |
| Agreement and repeatability Breathing Sequence | Other | 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. Receives: Device: Structured Light Plethysmography; Device: Pneumotachograph Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC) measured in Litres
The volume of air a person can exhale during a maximal forced breath
Measured: 5 minutes
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
Measured: 5 minutes
Peak Expiratory Flow (PEF) measured in litres per second
The maximal flow a person can achieve during a maximal forced breath
Measured: 5 minutes
Secondary outcomes (7)
Respiratory Waveform
Visual comparison of respiratory waveform shape and amplitude produced by pneumotachograph and SLP.
Measured: 5 minutes
Respiratory Rate (RR) measured in seconds
Tmings derived from the Respiratory Waveforms
Measured: 5 minutes
Inspiratory Time (tI) measured in seconds
Timings derived from the Respiratory Waveforms
Measured: 5 minutes
Expiratory Time (tE) measured in seconds
Timings derived from the Respiratory Waveforms
Measured: 5 minutes
Total breath time (tTot) measured in seconds
Timings derived from the Respiratory Waveforms
Measured: 5 minutes
Inspiratory/expiratory ratio (tI/tE) expressed as a ratio
Timing ratios derived from the Respiratory Waveforms
Measured: 5 minutes
The duty cycle (tI/tTot) expressed as a ratio
Timing ratios derived from the Respiratory Waveforms
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startJan 2011
- Primary completionJan 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pneumacare Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, University of Cambridge
- Responsible party
- Sponsor
- Investigators
- Karl Sylvester, PhD, Principal investigator, Addenbrookes University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598336
- Sponsor's protocol ID
- CIP01/0010
- Acronym
- SLPvsPNT
- Status last verified
- Jul 2018
- First submitted
- 3 Nov 2015
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11334135Bates 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.
PubMed 11292125Ferrigno 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.
PubMed 7836125Cala 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.
PubMed 9018522
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Structured Light Plethysmography Against Spirometry in Children and Adults
- ClinicalTrials.gov ID
- NCT02598336
- Acronym / sponsor ID
- SLPvsPNT / CIP01/0010
- Conditions
- Pulmonary Disease
- Keywords
- Structured Light Plethysmography, Spirometry, Pneumotachograph
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Pneumacare LtdIndustry (pharma, biotech, devices)
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, University of Cambridge
- Study start
- Jan 2011 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing Sequence | Other | Device: Structured Light Plethysmography, Device: Pneumotachograph SpirometrySimultaneous 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. |
| Agreement and repeatability Breathing Sequence | Other | Device: Structured Light Plethysmography, Device: Pneumotachograph SpirometrySimultaneous 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. |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Light PlethysmographyAlso: SLPNon contact device that uses light to record displacement of the anterior thorax and abdomen region | Device | Agreement and repeatability Breathing Sequence, Breathing Sequence |
| Pneumotachograph SpirometryDevice that measures airflow at the mouth using a mouthpiece | Device | Agreement and repeatability Breathing Sequence, Breathing Sequence |
Primary outcome
Forced Vital Capacity (FVC) measured in Litres
Time frame: 5 minutes
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
Time frame: 5 minutes
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
Time frame: 5 minutes
The maximal flow a person can achieve during a maximal forced breath
7 secondary outcomes
Respiratory Waveform
Time frame: 5 minutes
Respiratory Rate (RR) measured in seconds
Time frame: 5 minutes
Inspiratory Time (tI) measured in seconds
Time frame: 5 minutes
Expiratory Time (tE) measured in seconds
Time frame: 5 minutes
Total breath time (tTot) measured in seconds
Time frame: 5 minutes
Inspiratory/expiratory ratio (tI/tE) expressed as a ratio
Time frame: 5 minutes
The duty cycle (tI/tTot) expressed as a ratio
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Background: PubMed 11334135Stocks 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.
- Background: PubMed 11292125Bates 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.
- Background: PubMed 7836125Ferrigno 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.
- Background: PubMed 9018522Cala 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Sylvester, PhD principal investigator
Addenbrookes University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Light Plethysmography and Pneumotachograph Spirometry in people with Pulmonary Disease, run by Pneumacare Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC) measured in Litres (time frame: 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02598336, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018; AzTrials last refreshed its copy on 28 Oct 2026.