Thora-3DI™ for Evaluation of Severity of Chronic Obstructive Pulmonary Disease (COPD)

NCT03492359 | Completed DMC FDA Device

• 1 other identifier: SLP CL1
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate differences in tidal breathing patterns measured by SLP(Structured Light Plethysmography) between healthy subjects and COPD (chronic obstructive pulmonary disease). The correlation between SLP parameters and standard lung function parameters measured by body box and spirometry will also be assessed. Trends in SLP breathing patterns between the different GOLD (Global Initiative for Chronic Obstructive Lung Disease) stages of COPD, and between those and healthy subjects, will be investigated to assess whether SLP can detect differences between groups.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Structured Light Plethysmography, COPD severity

Outcome Measures

Primary Outcomes (6)

• Difference in SLP Breath Timing indices measured in seconds and between Patients and Healthy Subjects

  SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing

  Baseline

• Difference in SLP derived Relative Contribution (measured in %) between Patients and Healthy Subjects

  SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing that describes the contribution of a region of the thoracoabdominal wall to total displacement

  Baseline

• Difference in SLP derived Phase (measured in degrees) between Patients and Healthy Subjects

  SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing that describes the contribution of a region of the thoracoabdominal wall to total displacement

  Baseline

• Difference in SLP derived displacement rate derived parameters (measured in distance per second) between Patients and Healthy Subjects

  SLP breathing parameters derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing

  Baseline

• Difference in SLP displacement rate derived ratios between Patients and Healthy Subjects (measured in distance per second) between Patients and Healthy Subjects

  SLP breathing parameters ratios derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing

  Baseline

• Correlation between SLP parameters with lung Function parameters measured by spirometry and body box plethysmography ( FEV1; FEV1/FVC; TLC and RV)

  SLP breathing parameters ratios derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing correlated with lung function measured by body plethysmography and spirometry

  Baseline

Secondary Outcomes (1)

• The trends in tidal breathing patterns between varying severities of COPD (based on the GOLD grading system).

  Baseline

Study Arms (2)

Normal Control

ACTIVE COMPARATOR

Participants with no diagnosis of respiratory disease between the ages of 0 and 80 whose breathing will be measured using Thora-3Di structured light plethysmography, body plethysmography and spirometry.

Device: Thora-3Di; Device: Body Plethysmography; Device: Spirometry

COPD Patients

ACTIVE COMPARATOR

Participants with chronic obstructive pulmonary disease between the ages of 0 and 80 whose breathing will be measured using Thora-3Di structured light plethysmography, body plethysmography and spirometry.

Device: Thora-3Di; Device: Body Plethysmography; Device: Spirometry

Interventions

Thora-3Di DEVICE

Device that uses a grid of structured light to measure chest and abdominal wall movement

Also known as: Structured Light Plethysmography

COPD Patients; Normal Control

Body Plethysmography DEVICE

A pulmonary function test (PFT) for measuring total lung volume.

COPD Patients; Normal Control

Spirometry DEVICE

A pulmonary function tests (PFT) for measuring maximal forced expiratory flow and volume.

COPD Patients; Normal Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range 18-80 years,
• BMI range 18-40 kg/m2
• Patients diagnosed, or suspected, with COPD or normal subjects with no previous or current diagnosis of respiratory disease

You may not qualify if:

• Patient unable to sit in an upright position for required period of time
• Patients with significant co morbidities (assessed by the clinician at screening only):
• Significant unilateral lung disease e.g. pneumonectomy
• Chest wall or spinal deformity e.g. scoliosis
• Obstructive sleep apnea (OSA), Apnoea hypopnoea index \> 30 (if known)
• BMI\>40
• Inability to consent/comply with trial protocol
• Presence of an acute disease process that might interfere with test performance, e.g. Nausea, vomiting, persistent coughing)

Sponsors & Collaborators

• Landon Pediatric Foundation: lead
• Pneumacare Ltd: collaborator

Study Sites (1)

Ventura County Medical Center

Ventura, California, 93003, United States

Location

Related Publications (12)

• Ghezzi M, Tenero L, Piazza M, Bodini A, Piacentini G. Structured light plethysmography: new method to evaluate expiratory flow limitation in asthmatic children. Eur Respir J. 2015;46(suppl 59):PA3641.

  BACKGROUND

• Hmeidi H, Chadwick E, Lenney W, et al. IE50 measured by structured light plethysmography (SLP) can differentiate between children with and without asthma, and can detect response to a bronchodilator. Am J Respir Crit Care Med. 2016;193 Meeting Abstracts:A4505.

  BACKGROUND

• Hmeidi H, Chadwick E, Lenney W, et al. Structured light plethysmography (SLP) can quantify abnormal breathing in children aged 2-12 admitted with acute asthma. Am J Respir Crit Care Med. 2016;193 Meeting Abstracts:A4506.

  BACKGROUND

• Chen Y, Xin Z, Qin C. Analysis of tidal breathing flow-volume curves in stable COPD patients. Chinese J Prac Intern Med. 2005;11:978-980.

  BACKGROUND

• Kostianev S, Hristova A, Iluchev D. Characteristics of tidal expiratory flow pattern in healthy people and patient with chronic obstructive pulmonary disease. Folia Med (Plovdiv). 1999;41(3):18-25.

  PMID: 10658362 BACKGROUND

• Williams EM, Madgwick RG, Morris MJ. Tidal expired airflow patterns in adults with airway obstruction. Eur Respir J. 1998 Nov;12(5):1118-23. doi: 10.1183/09031936.98.12051118.

  PMID: 9864007 BACKGROUND

• Stick S. Measurements during tidal breathing. In: Stocks J, Sly P, Tepper R, Morgan W, eds. Infant respiratory function testing: Wiley-Liss; 1996:117-138.

  BACKGROUND

• Motamedi-Fakhr S, Wilson RC, Iles R. Tidal breathing patterns derived from structured light plethysmography in COPD patients compared with healthy subjects. Med Devices (Auckl). 2016 Dec 29;10:1-9. doi: 10.2147/MDER.S119868. eCollection 2017.

  PMID: 28096696 BACKGROUND

• Poole KA, Thompson JR, Hallinan HM, Beardsmore CS. Respiratory inductance plethysmography in healthy infants: a comparison of three calibration methods. Eur Respir J. 2000 Dec;16(6):1084-90. doi: 10.1034/j.1399-3003.2000.16f11.x.

  PMID: 11292110 BACKGROUND

• Parreira VF, Vieira DS, Myrrha MA, Pessoa IM, Lage SM, Britto RR. Optoelectronic plethysmography: a review of the literature. Rev Bras Fisioter. 2012 Nov-Dec;16(6):439-53. Epub 2012 Nov 27. English, Portuguese.

  PMID: 23184278 BACKGROUND

• de Boer W, Lasenby J, Cameron J, Wareham R, Ahmad S, Roach C et al.SLP:a zero-contact non-invasive method for pulmonary function testing. In: Labrosse F, Zwiggelaar R, Liu Y, Tiddeman B (eds). Proceedings of the British Machine Vision Conference. Aberystwyth: BMVA Press, 2010, 85.1-12. Availble at http://www.bmva.o

  BACKGROUND

• Whitley E, Ball J. Statistics review 4: sample size calculations. Crit Care. 2002 Aug;6(4):335-41. doi: 10.1186/cc1521. Epub 2002 May 10.

  PMID: 12225610 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Plethysmography, Whole Body; Spirometry

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plethysmography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: April 10, 2018
• Study Start: May 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: January 1, 2019
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

US (1)