None listed
Conditions
Brief summary
Background • Over 2 million people undergo heart surgery every year. • An invasive monitoring device called a ‘pulmonary artery catheter’ can measure how well the heart pumps, and is commonly used in heart surgery patients • Small studies suggest that pulmonary artery catheters may not benefit these patients, and may even lead to harm such as major bleeding and infection • Some experts conclude that pulmonary artery catheters overcomplicate things and lead to unnecessary and risky treatment • There has never been a high quality ‘randomised controlled trial’, so there is still uncertainty amongst doctors Aims • Our ultimate aim is to provide reliable evidence on whether heart surgery patients benefit from pulmonary artery catheters • First, we must test whether a large-scale trial is feasible by starting with a small ‘pilot study’ Methods • 150 patients undergoing low risk heart surgery will be eligible to participate • After providing informed consent and prior to surgery, participants will be allocated at random to receive either a pulmonary artery catheter or a less invasive alternative in a 1-to-1 ratio • We will record how smoothly the pilot study runs by collecting information on the number of patients we recruit, the number of times a person is switched from one strategy to another by their doctor, and how completely we can collect data and follow up patients • We will also assess whether pulmonary artery catheters influence a range of clinical outcomes in the intensive care unit, general ward, and at home after patients are discharged. Impact • If the PUMA Pilot is successful, the research team will conduct a large-scale randomised clinical trial that could change global practice
Interventions
Patients in the intervention group will have a pulmonary artery catheter inserted by a cardiac anaesthetist prior to surgery. At both trial sites, standard procedure involves insertion of an Edwards Swan-Ganz catheter (3 lumen, 7.5 Fr) through an Arrow Multi-lumen Access Catheter (MAC) sheath (9 or 8.5 Fr), although the specific type of pulmonary artery catheter and method of insertion is at the discretion of the treating consultant cardiac anaesthetist. We place no restriction on how data deriv
Patients in the intervention group will have a pulmonary artery catheter inserted by a cardiac anaesthetist prior to surgery. At both trial sites, standard procedure involves insertion of an Edwards Swan-Ganz catheter (3 lumen, 7.5 Fr) through an Arrow Multi-lumen Access Catheter (MAC) sheath (9 or 8.5 Fr), although the specific type of pulmonary artery catheter and method of insertion is at the discretion of the treating consultant cardiac anaesthetist. We place no restriction on how data derived from the pulmonary artery catheter is to be used by the treating clinicians (i.e. the study is pragmatic by design and does not include a protocol for goal-directed therapy). The duration of insertion for pulmonary artery catheters is at the sole discretion of the treating clinicians and will be different for each patient. The duration of insertion will be documented by the treating clinicians, cross referenced against the clinical record, and transcribed into case report forms.
Sponsors
Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Undergoing coronary artery bypass grafting OR isolated surgical aortic valve replacement or repair OR surgery on the aortic root or ascending aorta with or without aortic valve replacement. 2. Age > 18 years old
Exclusion criteria
1. Emergency procedures where surgery must be performed within 24 hours of the decision to operate (or before the start of the next business day) 2. Repeat or ‘re-do’ procedures 3. EuroSCORE II >2% 4. Pulmonary hypertension defined by right ventricular systolic pressure > 35 mmHg 5. Any degree of right ventricle systolic dysfunction as identified by cardiology report on most recent preoperative transthoracic echocardiogram. May be identified by cardiologist reported right ventricular systolic dysfunction, TAPSE < 15mm, or RVFAC < 35%. 6. Severe left ventricular systolic impairment (ejection fraction <30%) 7. Right-heart structural abnormality (e.g. severe tricuspid or pulmonary stenosis or regurgitation, tumour, atrial or ventricular septal defect)
Outcome results
None listed