Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000765224
Ethics application status
Approved
Date submitted
1/05/2018
Date registered
7/05/2018
Date last updated
6/07/2021
Date data sharing statement initially provided
23/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding the interactions between lung function and heart function in Chronic Obstructive Pulmonary Disease
Scientific title
The Effect of External Chest Compression on Right Ventricular End-Diastolic Volume in Chronic Obstructive Pulmonary Disease
Secondary ID [1] 294758 0
None
Universal Trial Number (UTN)
U1111-1213-2184
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 307656 0
Condition category
Condition code
Respiratory 306721 306721 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend three visits. The first two visits will be in the lung function laboratory at the Woolcock Institute of Medical Research. The third visit will be at the Specialist MRI Suite at Royal Prince Alfred Medical Centre. The three visits will be performed within a 4 week period and separated by at least one day.


Visit 1:
(2 hours)

Participants will complete a questionnaire to quantify the state of their breathing symptoms and the effect of this on their daily activity. Participants will then perform a series of simple breathing tests administered by a trained respiratory physiologist: (1.5 hours in total)
o Spirometry: This test is to determine how quickly your lungs can breathe air in and squeeze air out. You will need to suck and blow air as fast as you can and as forcefully as you can.
o Body plethysmography: This test is used to calculate how big your lungs are. This test will involve sitting inside a glass box and taking panting breaths following by very big breaths.
o Lung diffusing capacity: This test measures how well the air that you breathe is transported into your blood. We will also ask you take a big, quick breath of air containing a very small amount of carbon monoxide and a very small amount of nitrogen oxide. We will ask you to hold your breath for 10 seconds and then gently breathe all the air out of your lungs.
o Forced oscillation technique (FOT): This test measures the stiffness of the airways. This machine sends different sound waves through the air, making the air feel ‘wobbly’. This test involves sitting and breathing normally on a mouthpiece. We will also ask you take a big, easy breath in and gently breathe all the air out of your lungs.
o Multiple breath nitrogen washout test (MBNW): This test measure how evenly the air is distributed throughout your lungs. You will breathe into a mouthpiece, keeping the size of your breaths within a set range. During the test you will first breathe normal room air and then 100% oxygen for approximately 20 breaths. You will be asked to do this three times.
o Bronchodilator test: This is to see how well your lungs respond to an inhaled bronchodilator, which is a medication that relaxes the muscle around the airways and is increase the amount of airway you can breathe out. To determine whether your airways opened up after the bronchodilator, we will ask you to repeat the spirometry and FOT tests in the same way that you performed them earlier.

Visit 2:
(2 hours)

Participants will performing the following lung function tests, as described for visit 1; spirometry, body plethysmography and forced oscillation technique. A respiratory scientist will then place an elastic corset around the participant’s abdomen and chest, and the following lung function tests repeated; spirometry, body plethysmography, lung diffusing capacity, forced oscillation technique, multiple breath nitrogen washout and bronchodilator test. The elastic corset will be placed at the Xiphoid process (base of sternum) and tightness adjusted to reduce lung volume by 200-400mL, confirmed by body plethysmography. The elastic corset will be removed at the completion of the study visit.

Several different sizes of the elastic corset will be used throughout the study with the size chosen for each participant based upon individual waist circumference. Each corset has a range of widths that it can accommodate so that the degree of compression can be individualised for each patient. As the main goal of the elastic corset is to reduce lung volume, the degree of compression is likely to differ between patients to induce the desired reduction in volume.


Visit 3:
(2 hours)

Participants will begin by performing spirometry, as described for visit 1. Participants will wear noise-reducing headphones and lie on a table connected to a magnetic resonance image (MRI) scanner. The table will move into the MRI scanner and a cardiac MRI performed. During the test participants will be repeatedly asked to hold their breath for short periods (~10-15 seconds) whilst images of their heart are acquired. The cardiac MRI scan will take approximately 30min. After the first test a respiratory scientist will place the elastic corset around the participant’s abdomen and chest, and ask them to rest for 30min. The cardiac MRI scan will then be repeated with the participant wearing the elastic corset, which will again take approximately 30 min. The elastic corset will be removed at the completion of the study visit.
Intervention code [1] 301060 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305721 0
Indexed right ventricular end-diastolic volume measured by cardiac magnetic resonance imaging.
Timepoint [1] 305721 0
30 mins following placement of the corset at visit 3.
Secondary outcome [1] 346249 0
Right ventricular stroke volume measured by cardiac magnetic resonance imaging.
Timepoint [1] 346249 0
30 min following placement of the corset at visit 3
Secondary outcome [2] 346250 0
Right ventricular ejection fraction by cardiac magnetic resonance imaging.
Timepoint [2] 346250 0
30 min following placement of the corset at visit 3
Secondary outcome [3] 346251 0
Left ventricular end-diastolic volume measured by cardiac magnetic resonance imaging
Timepoint [3] 346251 0
30 min following placement of the corset at visit 3
Secondary outcome [4] 346326 0
Left ventricular stroke volume measured by cardiac magnetic resonance imaging.
Timepoint [4] 346326 0
30min after the placement of the corset at visit 3.
Secondary outcome [5] 346327 0
Left ventricular ejection fraction by cardiac magnetic resonance imaging.
Timepoint [5] 346327 0
30min after the placement of the corset at visit 3.
Secondary outcome [6] 346328 0
Left ventricular end-systolic volume measured by cardiac magnetic resonance imaging
Timepoint [6] 346328 0
30min after the placement of the corset at visit 3.

Eligibility
Key inclusion criteria
1. Willing and able to give written informed consent
2. Have a diagnosis of Chronic Obstructive Pulmonary Disease
3. History of current or past smoking with total smoking history greater than 10 years
4. Be hyperinflated (Residual Volume > 120% predicted)
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to perform the tests
2. Unable to withhold medication day of and day prior to study visit
3. Have had lung surgery
Have asthma, defined as a doctor diagnosis of asthma
5. Have had heart failure
6. Have uncontrolled/unstable arrhythmia
7. Have a non-MRI safe metallic prosthesis, such as a pacemaker or metal pin
8. Have claustrophobia
9. Have had an upper or lower respiratory tract infection in the six weeks prior to testing

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Cardiac MRI time is expensive and limited as there is one scanner for clinical and research usages. The lack of effect found during interim analyses didn't justify the significant resources required to complete the study.
Date of first participant enrolment
Anticipated
1/06/2018
Actual
1/08/2018
Date of last participant enrolment
Anticipated
27/09/2019
Actual
14/01/2019
Date of last data collection
Anticipated
25/10/2019
Actual
Sample size
Target
20
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10823 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 10824 0
Woolcock Institute of Medical Research - Glebe
Recruitment postcode(s) [1] 22564 0
2050 - Camperdown
Recruitment postcode(s) [2] 22565 0
2037 - Glebe

Funding & Sponsors
Funding source category [1] 299363 0
Charities/Societies/Foundations
Name [1] 299363 0
Woolcock Emphysema Centre Pilot Project Funding
Country [1] 299363 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Woolcock Institute of Medical Research
Address
431 Glebe Point Road,
Glebe NSW 2037
Country
Australia
Secondary sponsor category [1] 298642 0
None
Name [1] 298642 0
Address [1] 298642 0
Country [1] 298642 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300266 0
Sydney Local Health District
Ethics committee address [1] 300266 0
Ethics committee country [1] 300266 0
Australia
Date submitted for ethics approval [1] 300266 0
22/02/2018
Approval date [1] 300266 0
23/04/2018
Ethics approval number [1] 300266 0
X18-0041 & HREC/18/RPAH/64

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83094 0
Dr David Chapman
Address 83094 0
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe, NSW, 2037
Country 83094 0
Australia
Phone 83094 0
+61 2 9114 0413
Fax 83094 0
Email 83094 0
[email protected]
Contact person for public queries
Name 83095 0
David Chapman
Address 83095 0
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe, NSW, 2037
Country 83095 0
Australia
Phone 83095 0
+61 2 9114 0413
Fax 83095 0
Email 83095 0
[email protected]
Contact person for scientific queries
Name 83096 0
David Chapman
Address 83096 0
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe, NSW, 2037
Country 83096 0
Australia
Phone 83096 0
+61 2 9114 0413
Fax 83096 0
Email 83096 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.