Chronic Obstructive Pulmonary Disease Clinical Trial
— SLPCOPDOfficial title:
Tidal Breathing Patterns Measured by Thora-3DI™ Structured Light Plethysmography for Evaluation of Severity of Chronic Obstructive Pulmonary Disease (COPD)
NCT number | NCT03492359 |
Other study ID # | SLP CL1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | January 1, 2019 |
Verified date | May 2019 |
Source | Landon Pediatric Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 65 |
Est. completion date | January 1, 2019 |
Est. primary completion date | October 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
United States | Ventura County Medical Center | Ventura | California |
Lead Sponsor | Collaborator |
---|---|
Landon Pediatric Foundation | Pneumacare Ltd |
United States,
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.
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
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.
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.
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.
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. — View Citation
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. — View Citation
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. Review. English, Portuguese. — View Citation
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. — View Citation
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.
Whitley E, Ball J. Statistics review 4: sample size calculations. Crit Care. 2002 Aug;6(4):335-41. Epub 2002 May 10. Review. — View Citation
Williams EM, Madgwick RG, Morris MJ. Tidal expired airflow patterns in adults with airway obstruction. Eur Respir J. 1998 Nov;12(5):1118-23. Erratum in: Eur Respir J 1999 Jan;13(1):229. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | The trends in tidal breathing patterns between varying severities of COPD (based on the GOLD grading system). | The trends in tidal breathing patterns between varying severities of COPD as measured by the GOLD grading system. | Baseline |
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