None listed
Conditions
Brief summary
Open heart surgery is performed more than 2 million times each year worldwide. During and after surgery, doctors often use invasive devices to monitor the heart and blood vessels. One of these devices, the pulmonary artery catheter, provides detailed information about how the heart is functioning. Despite being widely used, it is still unclear whether this device actually helps patients recover better, because it has never been properly tested in a high-quality randomised trial. The PUMA study will address this question by randomly assigning adults undergoing open heart surgery to receive either a pulmonary artery catheter or standard care without one. We will compare outcomes that matter most to patients, including measures chosen with input from people with lived experience. This study will help determine whether routine use of this device improves recovery, safety, and overall outcomes after open heart surgery.
Interventions
Pulmonary Artery Catheter (PAC) Group:
Participants randomized to the PAC group will have a PAC inserted according to local policies and procedures by an experienced clinician prior to the start of surgery.
Typically inserted via the internal jugular vein and ‘floated’ to the pulmonary artery via the right heart, PACs generate data on cardiac output and other cardiopulmonary parameters that can be used to guide treatment decisions in the perioperative period.
The specific type of PAC and meth
Pulmonary Artery Catheter (PAC) Group: Participants randomized to the PAC group will have a PAC inserted according to local policies and procedures by an experienced clinician prior to the start of surgery. Typically inserted via the internal jugular vein and ‘floated’ to the pulmonary artery via the right heart, PACs generate data on cardiac output and other cardiopulmonary parameters that can be used to guide treatment decisions in the perioperative period. The specific type of PAC and method of insertion (including target insertion vessel and whether a vascular access sheath is used) is at the discretion of the treating consultant/attending cardiac anaesthesiologist. There are no restrictions on how data derived from the PAC is used by the treating clinicians (i.e. the study is pragmatic by design and does not include a protocol for goal-directed therapy (GDT)). The decision and timing of when to remove or replace the PAC is at the discretion of the relevant treating clinicians. The overall duration of use will be ascertained from review of medical records.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age >= 18 years • Undergoing cardiac surgery or surgery of the thoracic aorta
Exclusion criteria
• Predicted operative mortality >=3% based on the EuroSCORE II • Emergency surgery, defined as surgery that must be performed within 24 hours of the decision to operate or before the start of the next business day, whichever is sooner • Severe left ventricular systolic impairment (ejection fraction <30%) • Pulmonary hypertension, defined hierarchically as: o Mean pulmonary artery pressure (mPAP) = 20 mmHg based on the most recent formal right heart catheterisation (RHC) study conducted pre-operatively; else, if no RHC performed o Peak tricuspid regurgitant velocity (TRV) = 2.9 m.s-1 on the most recent pre- operative transthoracic echocardiogram; else, if TRV not reported o Right ventricular systolic pressure (RVSP) = 40 mmHg on the most recent pre- operative transthoracic echocardiogram • Right ventricular systolic impairment. May be identified by cardiologist reported right ventricular systolic dysfunction, TAPSE < 15mm, or RVFAC < 35% on pre-operative transthoracic echocardiography • Endovascular-only procedures • Cardiac transplantation • Contraindication to pulmonary artery catheterisation (e.g. severe tricuspid or pulmonary stenosis, right heart tumour, large atrial or ventricular septal defects) • Contraindication to transesophageal echocardiography (e.g. prior oesophagectomy, oesophageal pathology (tumour, stricture, perforation, diverticulum), active upper GI bleed) • Patients previously enrolled and randomized in PUMA.
Outcome results
None listed