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Spontaneous awakening trials: How to increase adherence in the ICU

From the September ACP Hospitalist, copyright © 2009 by the American College of Physicians

By Jessica Berthold

Research is one thing, and practice quite another. It’s been nine years since a New England Journal of Medicine study showed ICU patients recover more quickly when their sedation medication is routinely stopped. It’s been over a year and a half since a Lancet study found that combining this practice, called spontaneous awakening trials (SATs), with spontaneous breathing trials (SBTs) further decreased patients’ time on mechanical ventilation and in the ICU. Yet a sizable number of hospitals still don’t do it.

Seventy-six percent of ICUs have a written policy on SATs, but only 44% of them use SATs on more than half of ICU days, a March 2009 Critical Care Medicine survey found. The Journal of Critical Care also reported in March that just 40% of ICUs use SATs in more than half their patients.

The reasons for resistance are many. Some ICU staff don’t see the need for SATs, viewing light sedation as a more appropriate—and safer—substitute. Others claim they don’t have physician orders, or adequate staff, to undertake the protocols. And a sizable number simply aren’t convinced the practice will benefit patients.

“There is often a lot of effort put into researching and creating protocols, but the real money is in implementation,” said Curtis Sessler, MD, a professor of critical care medicine at Virginia Commonwealth University in Richmond. “It’s a hard thing to make an intervention the norm for practice.”

To speed the process along, experts said, it helps to have a champion—or champions—in the ICU who can present evidence for SATs, address staff concerns, devise a concise protocol, and monitor adherence to that protocol.

Find a champion

The SAT champion in the ICU can be practically anyone, as long as he or she is knowledgeable about the practice and can help educate and spark enthusiasm in others. Hospitalists involved in caring for the critically ill could take the opportunity to fill this role.

“It’s not one shoe fits all. The leader at one hospital may have a different background than the leader at another. But there does need to be someone at each center who can operationalize the effort,” said E. Wesley Ely, FACP, co-author of the Lancet and Critical Care Medicine articles, and critical care professor at Vanderbilt University in Nashville, Tenn.

No matter who leads the charge, physician support is important, because other members of the ICU staff will take cues from the doctors’ attitudes, he added. Indeed, the Journal of Critical Care article noted that 63% of nurses said the reason their hospitals didn’t use sedation protocols was “lack of physician orders.”

“If physicians are totally passive about it, then the rest of the team thinks there isn’t buy-in from the doctors, so why should they care about it?” Dr. Ely said. “There has to be passion from all sides.”

Yet, while a hospitalist or other doctor can spearhead an effort to start or increase SAT use, she or he shouldn’t be in charge of overseeing the effort on a daily basis, Dr. Ely cautioned.

“Doctors’ beepers are going off; they are going to clinics; they are running to codes and leaving the ICU,” Dr. Ely said. “It really needs to be a head nurse, or a head respiratory therapist. On each shift, there needs to be someone in charge and championing this.”

At Vanderbilt University Medical Center (VUMC), an interdisciplinary team of nurse, doctor and therapist meets every morning before rounds, and the nurse identifies herself or himself as the person in charge of doing SATs, he said. He or she communicates the results of all SATs to the respiratory therapist, who moves on to SBTs if appropriate.

“Then, when the nurse, therapist and doctor come together and talk about the results of the SATs and SBTs, they make a decision together about whether to extubate,” Dr. Ely said.

Keep it simple

A crucial step to successfully using SATs is to have a simple, written procedure in place, experts said. Many units don’t. The Journal of Critical Care article found only 64% of ICUs had sedation protocols. Even fewer had protocols for SATs.

“There are so many legitimate distractions in the ICU that you have to put in place some sort of standardization, to say that this will happen to every patient, every day, at a regular interval,” Dr. Ely said. “This has to be done in a rigid fashion, or it won’t happen at all.”

Dr. Ely recommends using the “Wake Up and Breathe” flow chart for SATs and SBTs, adapted from the Lancet study by him and his colleagues at VUMC. It’s available online.

“If possible, I’d encourage most ICUs to try it the way we did it, simply because this method has been tested, and we don’t know what kind of changes in outcomes might occur if the protocol is modified,” said Timothy Girard, MD, the Lancet study’s lead author and a critical care instructor at Vanderbilt University in Nashville, Tenn. “At the same time, have enough flexibility to make modifications that are needed to make it feasible for your particular ICU.”

Interest in the Wake Up and Breathe protocol, and SATs in general, appears to have increased since the Lancet publication, Dr. Girard added.

“We have received a lot of requests for our protocol from community hospitals and universities all over the country, and we’ve actually started to hear from hospitals that have implemented it, telling us they are getting good results,” Dr. Girard said.

Making the case

A common point of resistance to SATs is the argument that ICUs should strive to sedate patients as lightly as possible. If they are truly doing this, then an awakening trial would seem redundant, since most patients are, ideally, already somewhat awake.

“My question is—is there a universal or large need to do these [SATs]? There is always going to be a fraction of our patients who will need some degree of steady sedation, but are we underestimating the size of the population that could be awake most of the time?” asked Mark Siegel, ACP Member, director of critical care at Yale New Haven Hospital and associate professor at Yale University School of Medicine.

Indeed, when the original article on SATs was published in 2000, patients were awoken from heavy sedation, then sedated again after the trial. But the 2008 Lancet study actually included lightly sedated patients in both the control and intervention groups—and still found the latter spent less time in the ICU and on ventilators.

“We applied the protocol in the same way to all patients, regardless of whether they were lightly, intermittently or heavily sedated,” said Dr. Girard. “I agree it’s a little less intuitive to conduct an SAT in someone who is already somewhat awake due to light sedation, but the mechanics are the same. If the patient is getting intermittent doses, you simply hold the next dose.”

Why might an SAT still work in such a situation? Perhaps, in part, because patients often receive more sedation than critical care staff realize, Dr. Girard said.

“Despite our best intentions to lightly sedate patients, there have been studies done in the last couple years where researchers went into the ICU and tracked how much drug patients got,” Dr. Girard said. “They all indicate we sedate patients more heavily than we think.”

Fear and suspicion

The top barriers to using awakening trials in ICUs are lack of acceptance by nurses (22%) and staff concerns about patient self-extubation (19%), potential for respiratory compromise (26%), and patient discomfort (13%), according to the March 2009 Journal of Critical Care article.

Some of these concerns stem from a suspicion that stopping medication will have negative physical and psychological effects on patients, Dr. Girard noted. Yet a patient’s transition from medicated to unmedicated is more gradual than it appears, he said.

“When you turn these drugs off, the concentrations and the plasma in the brain only gradually decrease; they aren’t suddenly gone. So the patients wake up gradually,” Dr. Girard said. “We also have data [from the Lancet study] forthcoming which shows that the patients who underwent [SATs] didn’t have more psychological problems, even up to a year after study enrollment.”

A December 2003 study in the American Journal of Respiratory and Critical Care Medicine also found that ICU patients who’d undergone SATs had fewer signs of post-traumatic stress disorder after discharge than those who didn’t undergo SATs.

Concerns about self-extubation are well-founded, in a sense: The patients who underwent SATs in the Lancet study did have higher self-extubation rates than those undergoing usual care. However, the rate of reintubation by staff was the same in both groups, which suggests many of the SAT patients who self-extubated were actually ready to come off the ventilator earlier than the critical care team realized, Dr. Ely noted.

Even if the specific fears of reluctant staff are allayed, it may require some persistence to convince them SATs are a good idea. That’s because, unlike other medical procedures, the advantages aren’t always immediately obvious.

“If your blood pressure is low and you get a vasoactive drug, it rises and no one disagrees with that. If you turn a sedative off and the patient awakens, you don’t see the immediate benefit—that this person may leave the ICU early,” said John Kress, MD, director of the medical ICU at University of Chicago Medical Center, and author of the 2000 study on SATs. “It’s even harder if that person ends up getting a little agitated. A bad anecdote can undo a lot of good evidence.”

If the nurses, physicians and other staff keep at it, however, there will be no greater motivator than the success that eventually becomes apparent, Dr. Kress said.

“No matter whether you are the youngest graduate just out of nursing school or the most senior faculty member, when you walk out at the end of the day and something worked out well, you feel good about it,” Dr. Kress said. “You can punch a clock, or you can be the person who got a guy off a ventilator and out of the ICU today. And that’s really cool.”

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Mobility: The new frontier for intensive care units?

Though the struggle to ensure widespread use of spontaneous awakening trials is far from over, several progressive ICUs have turned their eyes toward the next challenge: mobility.

“I think the new protocol, instead of ‘Wake Up and Breathe,’ will be ‘Wake Up, Walk and Breathe,’“ said Dale Needham, MD, medical director of the Critical Care Physical Medicine and Rehabilitation Program at Johns Hopkins Hospital in Baltimore, where mobility in the ICU is encouraged.

The idea is to help ICU patients who successfully wake up after spontaneous awakening trials to sit up, and maybe take a few steps around the unit—all while still hooked to their ventilators. When ready, they can move on to spontaneous breathing trials.

Anecdotal evidence from several hospitals suggests the practice helps patients recover faster, and makes their ICU and post-ICU experiences more positive. A group led by John Kress, MD, director of the medical ICU at University of Chicago Medical Center, has conducted a randomized, controlled study of mobility trials, and results are forthcoming, according to Dr. Kress.

Just as most patients prefer to be on less, not more, medication, many would also rather be moving around than bedridden, Dr. Needham said.

“Patients uniformly tell us they like this—being awake and moving around,” he said. “If they get uncomfortable, they communicate that to us, usually by writing.”

For a long time, ICU staff assumed that having an oral endotracheal tube must be incredibly uncomfortable, and that patients simply couldn’t be awake, much less moving, with one in place. That was clearly wrong, Dr. Needham said.

“I now have many examples of where that simply isn’t true—to the point where patients are doing laps around the ICU with the oral ET tube in place, and writing us notes asking to do it again later that day,” Dr. Needham said.

Implementing mobility into patients’ routines requires having a physical therapist or occupational therapist on hand, which some ICUs may not. With luck, however, having such staff accessible will become de rigueur, proponents said.

“I definitely think we are moving in ICU medicine toward a much more interactive care plan,” said Timothy Girard, MD, an instructor in critical care medicine at Vanderbilt University in Nashville, Tenn. “It’s a very different approach than we did 10 to 20 years ago, where patients were basically all in a state of suspended animation.”

Click here to watch an interview with a Johns Hopkins patient who underwent a mobility trial.

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