NCT02598336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

July 10, 2018

Status Verified

July 1, 2018

Enrollment Period

6 years

First QC Date

November 3, 2015

Last Update Submit

July 7, 2018

Conditions

Pulmonary Disease

Keywords

Structured Light PlethysmographySpirometryPneumotachograph

Outcome Measures

Primary Outcomes (3)

  • Forced Vital Capacity (FVC) measured in Litres

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

    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

    5 minutes

  • Peak Expiratory Flow (PEF) measured in litres per second

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

    5 minutes

Secondary Outcomes (7)

  • Respiratory Waveform

    5 minutes

  • Respiratory Rate (RR) measured in seconds

    5 minutes

  • Inspiratory Time (tI) measured in seconds

    5 minutes

  • Expiratory Time (tE) measured in seconds

    5 minutes

  • Total breath time (tTot) measured in seconds

    5 minutes

  • +2 more secondary outcomes

Other Outcomes (1)

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

    5 minutes

Study Arms (2)

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.

Device: Structured Light PlethysmographyDevice: 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.

Device: Structured Light PlethysmographyDevice: Pneumotachograph Spirometry

Interventions

Structured Light PlethysmographyDEVICE

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

Also known as: SLP
Agreement and repeatability Breathing SequenceBreathing Sequence
Pneumotachograph SpirometryDEVICE

Device that measures airflow at the mouth using a mouthpiece

Agreement and repeatability Breathing SequenceBreathing Sequence

Eligibility Criteria

Age6 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge University Hospitals Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 11334135BACKGROUND

  • 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.

    PMID: 11292125BACKGROUND

  • 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.

    PMID: 7836125BACKGROUND

  • 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.

    PMID: 9018522BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Karl Sylvester, PhD

    Addenbrookes University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2015

First Posted

November 5, 2015

Study Start

January 1, 2011

Primary Completion

January 1, 2017

Study Completion

September 1, 2017

Last Updated

July 10, 2018

Record last verified: 2018-07

Locations

GB(1)