Coronary artery disease Circulatory System Ischaemic heart diseases
Conditions
Interventions
Coronary artery bypass grafting on the beating heart via a conventional median sternotomy (OPCAB-St) versus coronary artery bypass grafting on the beating heart via a left anterolateral thoracotomy (O
Sponsors
United Bristol NHS Healthcare Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All adults aged more than 16 years and less than 80 years having non-emergency, scheduled (urgent or elective) first-time off-pump surgery represent the target study population. Specific inclusion criteria: 1. Aged more than 16 and less than 80 years 2. Undergoing non-emergency, scheduled (urgent or elective) isolated coronary artery bypass grafting off-pump on the beating heart 3. Participating surgeon willing to carry out the operation via either surgical method
Exclusion criteria
Exclusion criteria: 1. No previous cardiac surgery 2. No previous lung surgery 3. Not in another invasive research study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the time until patients are classified as ?fit for discharge?. A patient must have a chest X-ray with no evidence of pleural effusion requiring drainage, lung collapse/consolidation or pneumothorax, no suspected infection, normal routine blood tests and temperature in order to be classified as fit for discharge. Susceptibility to bias of these components of the primary outcome will be minimised by documenting objective clinical signs and measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intraoperative measurement of cardiac output measured by Swan-Ganz catheter, when each distal anastomosis is being carried out on the target coronary arteries (consecutive sub-sample only, n = 40) 2. A participant?s judgement about his or her readiness for discharge when the above criteria are met (too soon, about right, could have been discharged earlier) 3. Biochemical inflammatory markers, i.e. complement activation (C3a and C5), interleukin (Interleukin 6 [IL6], Interleukin 8 [IL8] and Interleukin 10 [IL10]); these will be assessed at five time points, i.e. preoperatively, at the end of the operation, and 4, 12 and 24 hours post-operatively (consecutive sub-sample only, n = 60) 4. Alveolar/arterial gradient measured preoperatively (in the anaesthetic room), after extubation, and 1 day after extubation, from arterial blood samples taken through an existing arterial line 5 minutes after administering oxygen by mask, for each of three different oxygen concentrations (consecutive sub-sample only, n = 40) 5. Pulmonary function tests (PFTs) preoperatively and at discharge 6. Pain score measured with a 10 cm (0 to 100 mm) visual analogue scale, or by verbal response (0 to 100) if a participant is not well enough to use the visual analogue scale at 2, 12, 24 and 36 hours after extubation and on discharge 7. The total amount (volume and dose) of local anaesthetic (paravertebral block) and patient-controlled analgesia administered; post-operative days on which paracetamol and non-steroidal anti-inflammatory drugs were dispensed 8. Intensive Care Unit (ICU) and post-operative hospital stay 9. In-hospital mortality and other standard measures of morbidity, e.g. post-operative myocardial infarction (MI), stroke, arrhythmia, need for haemodynamic support, renal failure and wound infection 10. Use of healthcare resources and associated costs, e.g. duration of operation, ICU/High Dependancy Unit (HDU) and ward stay, additional interventions to treat complications, readmissi | — |
Countries
Italy, Trinidad and Tobago, United Kingdom
Outcome results
None listed