SAN FRANCISCO -- A daily protocol to bring ICU patients out of a drug-induced coma and breathing on their own gets them home four days faster, researchers said here.
SAN FRANCISCO, May 22 -- A daily protocol to bring ICU patients out of a drug-induced coma and breathing on their own gets them home four days faster, researchers said here.
In a randomized trial, the protocol also reduced ICU stays by four days and duration of ventilation by three days compared with standard ventilation weaning procedures, E. Wesley Ely, M.D., M.P.H., of Vanderbilt University in Nashville, Tenn., said at the American Thoracic Society meeting.
"The problem is that, while these drugs and the ventilator are put in place to both keep patients alive and help them be comfortable during their ICU stay, we don't remove them early enough," Dr. Ely said.
Mechanical ventilation weaning procedures and so-called sedation holidays "to see if the lights are on" for ICU patients are nothing new, said James M. Beck, M.D., of the University of Michigan at Ann Arbor, who commented on the study as conference chair.
But, "if you actually look at the execution in most ICUs, it may not be as standard as you think," he said.
Most ICU patients do not routinely receive either, "because ICU teams view them as difficult and not necessarily proven to help," Dr. Ely said.
So to demonstrate the safety and efficacy of combining daily interruption of sedatives and spontaneous breathing trials, Dr. Ely and colleagues conducted the Awakening and Breathing Controlled Trial (ABC). They randomized 355 adult non-surgical patients in four ICUs to the combined protocol or usual care with spontaneous breathing trials.
During the spontaneous breathing trials, patients were withdrawn from mechanical ventilation and monitored for oxygenation, airway pressure, agitation, myocardial ischemia, and other safety parameters.
The combined protocol called for a daily "wake up"-stopping sedation and monitoring for anxiety, agitation, pain, respiratory distress, arrhythmia, seizures and other factors. Then the breathing trial was attempted.
Predictors of mortality were similar between groups. Sequential Organ Failure Assessment (SOFA) scores averaged 8 for the control group and 9 for the combined protocol group (P=0.64). Acute Physiology and Chronic Health Evaluation (APACHE) II scores were nearly identical (26.5 versus 26.0, respectively).
Among the findings for the intervention compared with the control, the researchers reported:
The combination protocol group also received significantly lower total doses of benzodiazepines in the ICU (20 versus 39 mg, P=0.02) and tended to take less narcotic medication overall (2,662 versus 3,700 mcg, P=0.07).
Of the 1,140 spontaneous awakening trials, all of which were in the combination protocol group, 82% passed safety screens, the researchers noted. The most common reason for failure was patient agitation (13.2%).
They found that a similar proportion of spontaneous breathing trials in each group passed the safety screen (34% versus 35% control). The most common reason for failure was insufficient fraction of inspired oxygen when breathing (about 18% to 19% for both groups).
Self-extubation as an adverse event was significantly more common with the protocol (P=0.03). Reintubation was similar between groups (P=0.73).
"This 'wake up and breathe' strategy is safe and should be used for most medical ICU patients," the researchers concluded.
Because the protocol did not yield any improvement in delirium, which predicts ICU mortality, the investigators said further research is needed to identify management strategies that will treat delirium.
Dr. Ely said he thinks the excessive duration and dosing of sedative medication in the ICU may be at least partly responsible.
"It's well intentioned; doctors want patients to be comfortable," he said. But, "these drugs that we give too high and too long make patients misprocess information."
He said that half to a third of patients acquire a dementia-like impairment in memory and executive thinking that may last for months or years after ICU discharge.
He cited one patient who came back to him after being discharged reporting that she could no longer do her job because of the cognitive problems. The full neuropsychological battery of tests turned up an IQ of 110, which would not have been remarkable except that she had a documented IQ of 145 just a few years prior.
"This is a huge life-changing event," he said.
The researchers are now doing a 12-month follow-up of cognitive outcomes to see if a more detailed analysis will turn up advantages to the protocol.
One practical advantage that did turn up was financial.
Dr. Ely said that their "wake up and breathe" approach saved in the range of ,000 to ,000 per patient.
"Hundreds of thousands if not millions of patients every year around the world could benefit by simply standardizing or protocolizing this approach," he said. "This could actually have billions of dollars of implication for healthcare."