Validation of Structured Light Plethysmography - Health and Disease

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT02626468
• Lead Sponsor: Pneumacare Ltd

Brief Summary

Validation of Structured Light Plethysmography (SLP) in patients with conditions such as Chronic Obstructive Pulmonary Disease (COPD) that effect breathing and in healthy participants.

Detailed Description

The investigators hypothesize that SLP may be a useful tool to differentiate between different respiratory diseases. To further examine differences in disease and health, and between diseases SLP measurements will be recorded in a range of diagnostic conditions that effect breathing and in healthy normal subjects.

This is a non-randomised observational study to validate Structured Light Plethysmography in two groups of participants: those with Respiratory condition such as COPD and a normal healthy group. Neither group will receive any clinical intervention. SLP data capture and spirometry (as part of the patients clinical care) will be performed by the patients. The data collected from this study will allow examination of different breathing patterns between patients with different diseases, to compare breathing patterns in patients to those in healthy individuals, and to compare breathing patterns within a healthy population.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-10
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-07
• Last Update Posted: 2018-07-10
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Aged between 0 and 80 years

Exclusion Criteria

• Any contraindication to spirometry (if performed) or a history of a myocardial infarction or chest surgery within 4 weeks
• Patient unable to sit in an upright (or supine in the case of infants) position for required period of time
• Patients with significant co morbidities (assessed by the clinician at screening only):
• Chest wall or spinal deformity e.g. scoliosis
• Obstructive Sleep Apnoea (OSA) 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in SLP Breath Timing indices and measured in seconds and between Patients and Healthy Subjects	Baseline	SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing
Difference in SLP derived Relative Contribution (measured in %) between Patients and Healthy Subjects	Baseline	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
Difference in SLP derived Phase (measured in degrees) between Patients and Healthy Subjects	Baseline	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
Difference in SLP derived displacement rate derived parameters (measured in distance per second) between Patients and Healthy Subjects	Baseline	SLP breathing parameters derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing
Difference in SLP Breath Timing Ratios between Patients and Healthy Subjects	Baseline	SLP breathing parameters derived from the trace of movement over time of the thoracoabdominal (TA) wall during tidal breathing
Difference in SLP displacement rate derived ratios between Patients and Healthy Subjects (measured in distance per second) between Patients and Healthy Subjects	Baseline	SLP breathing parameters ratios derived from the trace of displacement rate over time of the thoracoabdominal (TA) wall during tidal breathing

Secondary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in 1 second (FEV1)	Baseline	Measurement of FEV1
Forced Vital Capacity (FVC)	Baseline	Measurement of FVC

Trial Locations

Locations (1)

Cambridge University Hospitals Foundation Trust; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom