How do tasks involving the upper limbs and trunk affect the sternum post-median sternotomy?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12614000073606

Acronym

SMaRT- Sternal Management and Review Trial

Enrollment

Registered

2014-01-21

Start date

2012-04-07

Completion date

2013-07-12

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

- The median sternotomy remains the gold standard incision for cardiac surgery procedures and involves division of the sternum (otherwise known as the breastbone) to access the heart and surrounding structures. - After such procedures, patients are routinely asked to follow precautions that restrict upper limb and trunk movements in order to allow the sternum to heal. - However, little is known regarding the sternal healing process and how upper limb and trunk movements affect this process following cardiac surgery. - The primary aim of this research project is to investigate how tasks involving the upper limbs and trunk affect the healing sternum over time. - To achieve this, the research team will measure how much movement occurs at the sternal edges during upper limb and trunk movements with the use of a 2D ultrasound machine. - 75 participants will be recruited to take part in this study. All participants will receive standard pre and post-operative care. - Nested within the above main study is a reliability study which aims to investigate the inter and intra-rater reliability of ultrasound measures of sternal micromotion during upper limb and trunk movements, in acute patients following cardiac surgery (first time point- 3-7 days post-operation). - The first 20 participants recruited to the main study will form the sample for the reliability study.

Interventions

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.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Outcome results