With PACs coming under scrutiny, it’s time to review policies, procedures
The key question: How much will it help?
New questions about an old critical care unit device the pulmonary artery catheter (PAC) are causing ICU managers to ask hard questions about the use of that invasive procedure. Or at least, they should be asking those questions, experts say.
A study published in the Journal of the American Medical Association (JAMA) last year1 raised new questions about the effectiveness of PACs and has sent critical care societies around the globe racing for answers. While a comprehensive answer may be far off, one piece of advice from the experts is consistent if you haven’t begun taking a hard look at PACs, now is the time to start.
"Look very critically at your patients and ask, What is the evidence that there is a harm?’" advises George Sopko, MD, cardiologist with the Bethesda, MD-based National Health, Lung and Blood Institute, which is becoming a key player in the debate. "First you want to do no harm. I would look at the populations of patients who are candidates for PA catheters and who may be at risk, and concentrate on that. Then I’d look at the patients who might benefit. Ask yourself, Do I need the information that the catheter provides me, and how well do I use the information?’"
Such questions gained renewed importance with the publication last year of a study in JAMA that not only questioned how much good PACs do, but also raised the possibility they might actually harm a large number of patients.1
The study by Alfred Connors, MD, et al, examined the outcomes of more than 5,700 critically ill patients in nine disease categories who had been admitted to ICUs in five medical centers. Pulmonary artery catheterization was performed on more than 2,100 of the patients, and each of those patients was paired with a patient with a comparable diagnosis who did not undergo a pulmonary artery procedure. Each of the outcome measures examined were worse for patients who were catheterized.
That study was accompanied by a JAMA editorial recommending either a randomized controlled clinical trial on the impact of PACs, or if that isn’t forthcoming, a Food and Drug Administration-issued moratorium on the use of the flow-directed catheters.
A coalition of critical care societies swung into action to examine the issue. In August, the group released an unprecedented Consensus Statement which opposed a moratorium but called for a series of actions that could lead to at least modified use of PACs. (For details of the statement, see story, at right.)
One of the first issues for an ICU manager to address is whether a PAC is actually needed, says Sopko. PACs have been considered a standard of care for decades, and there is a temptation to use them automatically. "But if you don’t use the information then you shouldn’t have put it in," he says. "And if you do put it in, make sure you have somebody who can interpret the data and act appropriately on the data."
The American Association of Critical-Care Nurses (AACN) in Aliso Viejo, CA, is preparing a protocol on the use of PACs, which should be available in January. "We’re trying to take the high road. If you’re going to use them, you need to use them correctly, meaning based on research, not just on what Dr. X is doing at this time," says Justine Medina, RN, MS, CCRN, clinical practice specialist with the AACN.
One of the first steps for an ICU manager is to take a hard look at the institution’s policies and procedures regarding use of PACs, she adds. She recalls a telephone call she received from a nurse educator who had been asked to review the competencies and validation of skills for all ICU nurses. That directive came after a relatively new nurse, under the direction of an intern, added air into PAC balloon because the catheter did not seem to be wedging. Then the nurse continued adding air until there was a "very serious negative outcome" for the patient, she says.
"The question in that case was, did you train that person, and were you certain the person knew what he or she was doing?" Medina says. "For the ICU manager who is dealing with high-frequency, high-risk procedures like pulmonary artery catheters, the difference between what people know and what they do can be pretty big. Be very clear on whether your procedure tells how to do it and whether you have a mechanism to determine if they’re really doing it." (For an example of how one hospital developed a procedure policy, see story, below right.)
She adds that this is also important for meeting the standards of the Joint Commission on Accreditation of Healthcare Organizations. "The attitude is that it doesn’t really care how you do your competency assessment, but you have to do one."
Use of PACs is an excellent topic for a quality assurance project, says Medina. "If you’re currently looking at the standard medication errors, falls, and the stuff that everyone does to death, you’re really missing the boat. If you use pulmonary artery catheters and there’s a question about whether nurses or physicians are doing it right, make that your project and make it multidisciplinary. Bring together all the people involved in it. Bring in a physician if you can, or at least someone to play that role so you have that point of view."
When the group is assembled, look at the use of PACs, including whether they are being administered in a timely fashion, and the kind of documentation you are doing, she says. Retrospective chart reviews are another good means for determining which patients can benefit from a PAC and which can’t, she says. Based on that, decide whether changes in care are needed in your PAC procedures. "Really pull the important stuff together and take it back to the bedside and get those nurses involved," she says.
Part of the problem facing critical care practitioners is that while some research data raise questions about the impact PACs have on patients, the data don’t show conclusively that the catheters universally produce negative outcomes, says Sopko.
"The concerns about the catheterization procedure have been in the literature for over a decade, and a lot of the reports have been pointing toward possible problems, with either no benefits or actual harm to patients. However, what we don’t know is whether or not this could be a reflection of a bias because of a specific populations being studied or the methodology being used."
Because PAC use has been considered a standard of care for critically ill patients, randomized double-blind trials have never been conducted because of ethical problems in withholding a procedure that was believed to useful, he notes. "But because of the new reports, there have been enough doubts generated that the professionals the experts in the field can say, Yes. Now we can do that.’"