A pilot study of pulmonary artery catheters in low-risk heart surgery.

Abstract

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