Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000073606
Ethics application status
Approved
Date submitted
30/12/2013
Date registered
21/01/2014
Date last updated
21/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
How do tasks involving the upper limbs and trunk affect the sternum post-median sternotomy?
Scientific title
How do tasks involving the upper limbs and trunk affect the sternum post-median sternotomy?
Secondary ID [1] 283751 0
Nil
Universal Trial Number (UTN)
Trial acronym
SMaRT- Sternal Management and Review Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiothoracic surgical patients 290724 0
Sternal micromotion (movement that occurs at the sternal edges) 290725 0
Condition category
Condition code
Cardiovascular 291088 291088 0 0
Coronary heart disease
Surgery 291089 291089 0 0
Other surgery
Physical Medicine / Rehabilitation 291235 291235 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
MAIN STUDY (Observational study):
Main outcome measure is sternal micromotion (movement that occurs at the sternal edges) at rest and during five functional tasks (deep inspiration, cough, upper limb elevation (unilateral and bilateral) and sit to stand) at 3 time points (3-7 days, 6 weeks and 3 months post-operation). Ultrasound (Sonosite M-Turbo device) will be used to capture real-time, 2D images of the sternum during each of the above tasks. A software program (MicroDicom) will then be used to measure the amount of sternal micromotion.

NESTED STUDY (Reliability study):
Main outcome measure is sternal micromotion (movement that occurs at the sternal edges) at rest and during five functional tasks (deep inspiration, cough, upper limb elevation (unilateral and bilateral) and sit to stand) at 1 time point (3-7 days post-operation). Each task will be repeated three times and the order randomized. Ultrasound (Sonosite M-Turbo device) will be used to capture real-time, 2D images of the sternum during each of the above tasks. Two observers, blinded to the participant and task will then use a software program (MicroDicom) to measure the amount of sternal micromotion.
Intervention code [1] 288498 0
Not applicable
Comparator / control treatment
No comparator/control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291072 0
Sternal micromotion (movement that occurs at the sternal edges) using 2D ultrasound
Timepoint [1] 291072 0
3-7 days, 6 weeks and 3 months post-operation
Secondary outcome [1] 305966 0
Sternal pain (visual analogue scale)
Timepoint [1] 305966 0
3-7 days, 6 weeks and 3 months post-operation
Secondary outcome [2] 305967 0
Function (functional disability questionnaire; brief pain inventory- short form)
Timepoint [2] 305967 0
3-7 days, 6 weeks and 3 months post-operation
Secondary outcome [3] 305968 0
Sternal instability (sternal instability scale):
The sternal instability scale is a manual test that measures the stability of the sternum based on a 4-point scale. A score of 0 corresponds to a clinically stable sternum with no detectable motion or separation of the sternal edges, whilst a score of 3 corresponds to a completely separated sternum with marked increased motion or separation of the sternal edges.
Timepoint [3] 305968 0
3-7 days, 6 weeks and 3 months post-operation

Eligibility
Key inclusion criteria
Patients:
1. who have undergone an elective or emergency cardiac surgical procedure, involving a median sternotomy.
2. over the age of 18 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients:
1. with insufficient English comprehension to provide informed consent, complete simple, written questionnaires and/or understand simple, verbal instructions.
2. unable to participate in visual testing methods, including VASs and simple, written questionnaires.
3. deemed medically unstable by their respective cardiothoracic surgeons/teams pre-operatively or post-operatively, preventing them from participation in the testing procedures. This includes patients who are hemodynamically unstable, with a heart transplant or ventricular assist device, requiring intra-aortic balloon pump support, in respiratory distress/failure, requiring ongoing intubation or non-invasive respiratory support or who have suffered an acute neurological event, such as a cerebrovascular accident.
4. with impaired cognition or in a confused state thus preventing them from being able to provide informed consent, complete simple, written questionnaires and/or understand simple, verbal instructions. This includes patients with severe dementia, suffering an intellectual disability or diagnosed with an acute delirium.
5. with a physical impairment that prevents them from participating in the upper limb and trunk tasks tested in the ultrasound component. This includes patients who have been diagnosed with severe osteoarthritis, significant rotator cuff injury or who are bed/wheelchair bound.
6. who have undergone cardiopulmonary resuscitation post-operatively.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample Size (MAIN STUDY):
The sample size calculation is informed by the results of a previous study conducted by El-Ansary et. al (2007) who found that the mean micromotion of the sternal edges in participants with chronic sternal instability was 11.5mm (with a standard deviation of 2.9 units). This represents a large effect size (f=0.4). Given that the patient population for this study will not have chronic sternal instability, the research team expects a smaller mean micromotion of the sternal edges. Therefore, using a moderate effect size for a one way ANOVA for repeated measures (f=0.25), the research team will need 64 participants at Beta=0.8 and Alpha=0.05. In order to account for a potential participant drop-out rate of 15%, the research team will aim to recruit 75 participants.

Sample Size (NESTED RELIABILITY STUDY of day 3-7 sternal micromotion measures):
For the inter-rater reliability component of the study, the research team expects an intra-class correlation coefficient of 0.90, but will accept a minimum value of 0.70. Therefore, a total of at least 19 participants are required, at Beta=0.2, Alpha=0.05.

Statistical Analysis (MAIN STUDY):
The primary outcome measure of the mean micromotion of the sternal edges as well as the BPI short form and FDQ will be analysed using repeated measures within subjects ANOVA. Additionally, this data will be presented as a mean difference (+/- 95% confidence interval) at each time point. The mean micromotion of the sternal edges data will also be analysed using repeated measures ANCOVA, with mean VAS used as a covariate. Based on the data collected for the mean micromotion of the sternal edges, the research team will define a cut-off value for whether a participant has sternal instability or not. This cut-off value will be informed by previous research which has found that the mean micromotion of the sternal edges in patients diagnosed with chronic sternal instability is 11.5mm (with a standard deviation of 2.9 units). Values above and below the cut-off value will be used as a nominal dependent variable in logistic regression analysis. The research team will enter up to 5 variables into the logistic regression to assess relationships between sternal instability and risk factors that are significant on univariate analyses. The SIS will be analysed using Friedman’s test for within subjects, non-parametric, repeated measures data. Correlation of the BPI short form, FDQ, VAS and SIS with the primary outcome measure will be calculated using Spearman’s correlation coefficient. The overall level of statistical significance will be set at a p-value of less than 0.05.

Statistical Analysis (NESTED RELIABILITY STUDY of day 3-7 sternal micromotion measures):
The inter and intra-rater reliability of the ultrasound measures will be examined using intra-class correlation coefficients and Bland-Altman plots.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/04/2012
Actual
7/04/2012
Date of last participant enrolment
Anticipated
30/06/2013
Actual
12/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1850 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 1851 0
Melbourne Private Hospital - Parkville
Recruitment postcode(s) [1] 7655 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [2] 7656 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 288421 0
Self funded/Unfunded
Name [1] 288421 0
Country [1] 288421 0
Primary sponsor type
Individual
Name
Sulakshana Balachandran
Address
Physiotherapy Department, The University of Melbourne
Alan Gilbert Building, Level 7
161 Barry Street, Parkville, Victoria 3010
Country
Australia
Secondary sponsor category [1] 287173 0
None
Name [1] 287173 0
Address [1] 287173 0
Country [1] 287173 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290338 0
Melbourne Human Health Research Ethics Committee
Ethics committee address [1] 290338 0
Ethics committee country [1] 290338 0
Australia
Date submitted for ethics approval [1] 290338 0
14/12/2011
Approval date [1] 290338 0
08/02/2012
Ethics approval number [1] 290338 0
2011.240

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

Contacts
Principal investigator
Name 44934 0
Prof Alistair Royse
Address 44934 0
Royal Melbourne Hospital- City Campus
300 Grattan Street, Parkville, Victoria 3050
Country 44934 0
Australia
Phone 44934 0
+61 39342 7000
Fax 44934 0
Email 44934 0
[email protected]
Contact person for public queries
Name 44935 0
Sulakshana Balachandran
Address 44935 0
Physiotherapy Department, The University of Melbourne
Alan Gilbert Building, Level 7
161 Barry Street, Parkville, Victoria 3010
Country 44935 0
Australia
Phone 44935 0
+61 407 834 822
Fax 44935 0
Email 44935 0
[email protected]
Contact person for scientific queries
Name 44936 0
Sulakshana Balachandran
Address 44936 0
Physiotherapy Department, The University of Melbourne
Alan Gilbert Building, Level 7
161 Barry Street, Parkville, Victoria 3010
Country 44936 0
Australia
Phone 44936 0
+61 407 834 822
Fax 44936 0
Email 44936 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseMotion at the Sternal Edges During Upper Limb and Trunk Tasks In-Vivo as Measured by Real-Time Ultrasound Following Cardiac Surgery: A Three-Month Prospective, Observational Study.2019https://dx.doi.org/10.1016/j.hlc.2018.05.195
N.B. These documents automatically identified may not have been verified by the study sponsor.