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Strengths of the study include the "importance of the research question, the careful consideration of
the comparator groups based on strong physiological rationale, and the complete follow-up," write Dr.
Jeremy Kahn of University of Pittsburgh School of Medicine and Dr. Shannon Carson of University of
North Carolina, Chapel Hill.
Several limitations are also worth noting, they say. The primary outcome was duration of ventilator
weaning, which, although important, is not necessarily patient-centered. Truly patient-centered
outcomes such as the percentage of patients successfully weaned and one-year mortality were not
significantly different between groups.
"Additionally, contrary to published protocols, patients in the pressure support group were not rested
on full ventilator support (i.e., 'assist control') at night. The efficacy of daily unassisted breathing
compared with daily reductions in pressure support when both groups are rested on assist control at
night is a critical but unanswered research question. In addition, the study was conducted at a single
LTACH and the generalizability of the findings is unknown," they point out.
Drs. Kahn and Carson also think this study "elegantly" demonstrates the consequences of current
Centers for Medicare & Medicaid Services (CMS) regulations that define LTACHs not by the patients
they admit or the services they provide but their average length of stay, which by rule must exceed an
average of 25 days.
Thirty-two percent of enrolled patients demonstrated an ability to breathe unassisted for five days
during the initial breathing trial, and thus were not randomized in the trial, they explain. This finding,
they say, suggests that many patients sent to LTACHs for "failure to wean" from the ventilator may
have experienced "failure to attempt to wean" from the ventilator.
"Those patients might have remained in an ICU, potentially saving the costs associated with a second
hospitalization. An objective test such as an inability to breathe via tracheostomy tube for a specified
amount of time may be a useful benchmark for LTACH admission. This idea requires external
validation, however, because the patients in this study may have required LTACH care for other
reasons, irrespective of their perceived ventilator dependence," the editorialists conclude.
They also think this trial shows that it's feasible to open the "black box" that clinical care in LTACHs
exists in, where ventilator management and other aspects of patient care are guided by clinical
experience and intuition rather than robust trial data.
"Large-scale clinical trials are not just feasible but essential in defining best practice, developing
admission standards, and better understanding the increasing role of LTACHs for patients recovering
from chronic critical illness," Dr. Kahn and Dr. Carson conclude.
The
National
Institute
of
Nursing
Research
provided
funding
for
the
study.