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Validation of Structured Light Plethysmography (SLPvsPNT)

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ClinicalTrials.gov Identifier: NCT02598336
Recruitment Status : Completed
First Posted : November 5, 2015
Last Update Posted : July 10, 2018
Sponsor:
Collaborators:
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
Information provided by (Responsible Party):
Pneumacare Ltd

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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease Device: Structured Light Plethysmography Device: Pneumotachograph Spirometry Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Validation of Structured Light Plethysmography Against Spirometry in Children and Adults
Actual Study Start Date : January 2011
Actual Primary Completion Date : January 2017
Actual Study Completion Date : September 2017

Arm Intervention/treatment
Breathing Sequence
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.
Device: Structured Light Plethysmography
Non contact device that uses light to record displacement of the anterior thorax and abdomen region
Other Name: SLP

Device: Pneumotachograph Spirometry
Device that measures airflow at the mouth using a mouthpiece

Agreement and repeatability Breathing Sequence
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.
Device: Structured Light Plethysmography
Non contact device that uses light to record displacement of the anterior thorax and abdomen region
Other Name: SLP

Device: Pneumotachograph Spirometry
Device that measures airflow at the mouth using a mouthpiece




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   6 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598336


Locations
United Kingdom
Cambridge University Hospitals Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Pneumacare Ltd
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
Investigators
Principal Investigator: Karl Sylvester, PhD Addenbrookes University Hospitals NHS Trust

Publications:
Responsible Party: Pneumacare Ltd
ClinicalTrials.gov Identifier: NCT02598336     History of Changes
Other Study ID Numbers: CIP01/0010
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018

Keywords provided by Pneumacare Ltd:
Structured Light Plethysmography
Spirometry
Pneumotachograph

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases