Cardiac Surgery via Median Sternotomy Surgery Cardiac surgery via median sternotomy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Anticipated elective cardiac surgical procedure, involving a median sternotomy at Hospital Canselor Tuanku Muhriz 2. Able to provide informed consent 3. Aged =18 years.
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 21/07/2020: 1. Insufficient Malay/English comprehension to provide informed consent, complete simple, written questionnaires and/or understand simple, verbal instructions. 2. High risk patients with admission in ICU with Intra-aortic balloon pump (IABP) or without IABP (as determined by their respective cardiothoracic surgeons/team pre-operatively) 3. Physical impairment that prevents participation in the upper/lower limb and trunk tasks tested in the functional task components. This includes patients who have been diagnosed with severe osteoarthritis, significant rotator cuff injury or who are bed/wheelchair-bound Previous participant exclusion criteria: 1. Insufficient Malay/English comprehension to provide informed consent, complete simple, written questionnaires and/or understand simple, verbal instructions. 2. Deterioration in patient’s condition as determined by their respective cardiothoracic surgeons/teams pre-operatively 3. Unstable coronary or other medical condition 4. Physical impairment that prevents participation in the upper/lower limb and trunk tasks tested in the functional task components. This includes patients who have been diagnosed with severe osteoarthritis, significant rotator cuff injury or who are bed/wheelchair-bound
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 21/07/2020: Upper limb exercise capacity measured using the unsupported limb exercise test prior to discharge, at 4 weeks, and 3 months Previous primary outcome measure: Upper limb exercise capacity measured using the unsupported limb exercise test at discharge (or 7 days), 4 weeks, and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 21/07/2020: 1. Pain measured by the Numerical Rating Scale For Pain (NPRS) and the Visual Analog Scale (VAS) for pain prior to discharge prior (or 7 days), at 4 weeks, and 3 months 2. Thoracic physical function measured by the Functional Difficulty Questionnaire (FDQ) shortened version prior to discharge (or 7 days), at 4 weeks, and 3 months 3. Multi-domain recovery measured by the Postoperative Quality Recovery Scale (PostopQRS) prior to discharge (or 7 days), at 4 weeks, and 3 months 4. Functional exercise capacity measured by the 6-Min Walk Test (6MWT) prior to discharge (or 7 days), at 4 weeks, and 3 months 5. Levels of anxiety and depression measured using the Hospital Anxiety and Depression Scale ( HADS prior to discharge (or 7 days), at 4 weeks, and 3 months 6. Sternal stability measured using the Sternal Instability Scale (SIS) prior to discharge (or 7 days), at 4 weeks, and 3 months 7. Handgrip strength (kg) measured using a handheld dynamometer prior to discharge (or 7 days), at 4 weeks, and 3 months 8. Self-perceived recovery of physical function and quality of life measured using the modified Iowa Level of Assistance Scale (mILOA), the World Health Organisation Disability Assessment Schedule V2 (WHODAS), the Self-Assessment of Physical Activity Questionnaire (SAQ), and the Global Rating of Change (GRC) scales at discharge (or 7 days), 4 weeks, and 3 months 9. Respiratory Complications/Sternal Complications assessed through hospital notes at discharge (or 7 days), or via phone at 4 weeks, and 3 months 10. Hospital Length of Stay (LOS) assessed through hospital notes at discharge 11. Discharge Destination assessed through hospital notes prior to discharge (or 7 days), at 4 weeks, and 3 months 12. Major adverse and cerebral events (MACCE) assessed through hospital notes at discharge (or 7 days), or via phone at 4 weeks, and 3 months Previous secondary outcome measures: 1. Pain measured by the Numerical Ratin | — |
Countries
Malaysia