Chronic Lung DiseaseNCT02328430
Feasibility and Validity of Remote Lung Function Assessment
An observational study of Chronic Lung Disease, run by North Bristol NHS Trust at 1 site in United Kingdom.
Trial summary
Comparison of standard spirometry to non invasive remote lung function measures of chest wall movement using depth camera technology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Lung Disease
- What is being tested?
- Kinnect 3 camera
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients attending UK secondary care outpatient department in respiratory medicine and how are scheduled to undergo spirometry
Who may be able to join
- Patients attending outpatient department in respiratory medicine.
- Scheduled to undergo spirometry -
Who cannot join
- Unable to give informed consent
- Unable to perform spirometry -
Trial locations and contacts
1 site in 1 country.
Deborah Warbrick, BSc contact
About this study
Official title: Comparison of Remote Camera Measures of Lung Function Compared to Standard Spirometry
Comparison of standard spirometry to non invasive remote lung function measures of chest wall movement using depth camera technology.
Read the detailed description
This study plans to test a new non invasive way of measuring lung function and compare it to the current method of blowing into a spirometer.
Spirometry is an essential investigation for diagnosis and assessment of severity in people with Chronic Obstructive Pulmonary Disease (COPD) and other respiratory conditions, it is used in every respiratory unit and across primary care. It requires subjects to blow into a tube which measures volume and flow of expired air. It involves specialist equipment and training to perform and interpret. Not all patients are capable of performing spirometry, in particular children, frail, cognitively impaired and those experiencing a flare or exacerbation of symptoms. Remote lung function assessment technology has the potential to enable assessment of lung function in these groups of patients. In the future it is also hoped that it could be used to improve respiratory disease monitoring outside the healthcare environment such as in the patients home.
This new method uses the latest infra-red depth detection cameras to measure chest wall movement. (N.B this does not capture identifiable images). We would like to record participants chest wall movements while blowing into the spirometer.
- Conditions
- Chronic Lung Disease
- Being tested
- Kinnect 3 camera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinnect 3 cameraDevice
comparison of Kinnect 3 measures of chest wall movement during standard spirometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between change in chest wall depth and Forced Expiratory Volume in 1 second (FEV1)
Change in lung volume over time (litre per minute)
Measured: participants will be followed up for the duration of outpatient visit - on average 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Bristol NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bristol
- Responsible party
- Sponsor
- Investigators
- James W Dodd, MB CHB PhD, Principal investigator, Academic Clinical Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328430
- Sponsor's protocol ID
- 3480
- Status last verified
- Dec 2014
- First submitted
- 19 Dec 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Remote Camera Measures of Lung Function Compared to Standard Spirometry
- ClinicalTrials.gov ID
- NCT02328430
- Acronym / sponsor ID
- 3480
- Conditions
- Chronic Lung Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- North Bristol NHS TrustUniversity, hospital or other
- Collaborators
- University of Bristol
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of standard spirometry to non invasive remote lung function measures of chest wall movement using depth camera technology.
Detailed description
This study plans to test a new non invasive way of measuring lung function and compare it to the current method of blowing into a spirometer.
Spirometry is an essential investigation for diagnosis and assessment of severity in people with Chronic Obstructive Pulmonary Disease (COPD) and other respiratory conditions, it is used in every respiratory unit and across primary care. It requires subjects to blow into a tube which measures volume and flow of expired air. It involves specialist equipment and training to perform and interpret. Not all patients are capable of performing spirometry, in particular children, frail, cognitively impaired and those experiencing a flare or exacerbation of symptoms. Remote lung function assessment technology has the potential to enable assessment of lung function in these groups of patients. In the future it is also hoped that it could be used to improve respiratory disease monitoring outside the healthcare environment such as in the patients home.
This new method uses the latest infra-red depth detection cameras to measure chest wall movement. (N.B this does not capture identifiable images). We would like to record participants chest wall movements while blowing into the spirometer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending UK secondary care outpatient department in respiratory medicine and how are scheduled to undergo spirometry
Key inclusion criteria (2 listed)
- Patients attending outpatient department in respiratory medicine.
- Scheduled to undergo spirometry -
Key exclusion criteria (2 listed)
- Unable to give informed consent
- Unable to perform spirometry -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinnect 3 cameracomparison of Kinnect 3 measures of chest wall movement during standard spirometry | Device | – |
Primary outcome
Correlation between change in chest wall depth and Forced Expiratory Volume in 1 second (FEV1)
Time frame: participants will be followed up for the duration of outpatient visit - on average 3 hours
Change in lung volume over time (litre per minute)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Warbrick, BSc contact
James W Dodd, MB CHB PhD principal investigator
Academic Clinical Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lung Disease, run by North Bristol NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James W Dodd, MB CHB PhD (01174147925, james.dodd@bris.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between change in chest wall depth and Forced Expiratory Volume in 1 second (FEV1) (time frame: participants will be followed up for the duration of outpatient visit - on average 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.