Validation of Structured Light Plethysmography: Asthma

Asthma Clinical Trial

— SLPBD  

Official title:

Validation of Structured Light Plethysmography: Pre- and Post- Bronchodilator Challenge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543333
• Other study ID #: PMC-T3D-002/2
• Status: Completed
• Start date: July 2013
• Est. completion date: July 2016

Study information

• Verified date: July 2018
• Source: Pneumacare Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Validation of Structured Light Plethysmography (SLP) in patients with asthma, in patients with acute asthma; an observational study in healthy participants and during patients' clinical investigation of broncho-reversibility in the asthma groups.

Description:

A non-randomised observational study to validate Structured Light Plethysmography in three groups of participants: those with stable asthma and those with acute asthma, who are undergoing routine clinical investigation of broncho-reversibility using spirometry. We will also observe a normal healthy group who will receive no clinical intervention. SLP data capture and spirometry (as part of the patients clinical care) will be performed before and after a Bronchodilator reversibility test which is part of the patients normal clinical care (except in the normal healthy group where no bronchodilator will be given). The data collected from this study will allow us to examine the effect of bronchodilators on breathing patterns in these patients and also compare breathing patterns in asthma patients to those in healthy individuals.

The participant will wear a plain white t-shirt. Alternatively, the measurement can be taken on bare skin or with the participant (if female) wearing a plain material white bra. The participant is asked to sit down on a chair or lie down with their neck in a neutral position and their back as straight as possible in front of the SLP device (Thora-3Di, Pneumacare Ltd). The projector is lined up to project the grid of light over the participant's chest and upper abdomen. and will be instructed to perform a period of 5 minutes of tidal breathing, They will otherwise be asked to remain as still as possible throughout the measurement. During the sequence of breathing, thoracoabdominal wall movements will be captured by the device.

participant on completion of their Bronchodilator Challenge within the Lung Function Department or clinic

The SLP measurement is repeated on completion of their Bronchodilator reversibility test within the Lung Function Department or clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 80 Years

Eligibility

Inclusion Criteria:

• Aged between 2 and 80 years

Exclusion Criteria:

• Patients with significant co morbidities resulting in clinical instability (assessed by the clinician at screening only):

• obstructive sleep apnea, Apnoea hypopnoea index > 30 (if known)

• An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in the study

• BMI > 40

• Inability to consent/comply with trial protocol

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals Foundation Trust	Cambridge	Cambridgeshire
United Kingdom	Royal Stoke University Hospital	Stoke on Trent	Staffordshire

Sponsors (4)

Lead Sponsor	Collaborator
Pneumacare Ltd	Cambridge University Hospitals NHS Foundation Trust, Keele University, University Hospitals of North Midlands NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

de Boer WH, Lasenby J, Cameron J, Wareham R, Ahmad S, Roach C, Hills W, Iles R. 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. BMVA Press, 2010; pp 85.1-85.12

Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. General considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. Review. — View Citation

Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. — View Citation

Morgan MD, Gourlay AR, Denison DM. An optical method of studying the shape and movement of the chest wall in recumbent patients. Thorax. 1984 Feb;39(2):101-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in SLP Parameters after Bronchodilator Reversibility Test	SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing.	Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
Primary	Difference in SLP Parameters between Asthma Patients and Healthy Subjects	SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing.	Baseline
Secondary	Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) after Bronchodilator Reversibility Test	Measurement of FEV1 before and after bronchodilator	Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
Secondary	Change from Baseline in Forced Vital Capacity (FVC) after Bronchodilator Reversibility Test	Measurement of FEV1 before and after bronchodilator	Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)