Use of a Non-ICU Specialty Ward For Immediate Post-operative Management of Head and Neck Free Flaps

Free flaps are an instrumental component of head and neck reconstructive surgery. There is no
current consensus on the postoperative management of these patients despite the increasing
frequency with which free flaps are used. Although patients often do not have a specific
medical indication for postoperative ICU management, they frequently are sent to the ICU for
postoperative care based on the need for close nurse monitoring of the flap. In a US based
survey in 2007, 88.9% of head and neck surgeons were sending postoperative flap patients to
the ICU. Typical ICU length of stay for these patients varies from 2-11 days. There are
numerous theoretic disadvantages to ICU care in these patients. ICU care has been associated
with increased use of sedation leading to decreased flap perfusion, prolonged use of
ventilation, less self care, less ambulation, increased delirium and increased cost.

Due to these concerns, several institutions have developed protocols that allow for the
monitoring of head and neck free-flap patients outside of the ICU. Two recent retrospective
studies assessed outcomes using these protocols, including 257 patients (119 ICU, 138 ward)
and showed no significant difference in morbidity and mortality, or flap failure between the
groups. There was a significant increase LOS from 8 to 9 days and transfusion rate, in the
ICU group. Another study looked at 247 patients (175 ICU, 72 ward) and found no difference
between flap failure, reoperation, hematoma, wound complications between the groups. They
also found an increased LOS from 7 to 8 days in the ICU group. They calculated cost
difference and found a decrease in average patient cost from $101,199 to $86,195 in the ward
group. These studies support the use of non-ICU care for head and neck free-flap patients,
however given their retrospective nature significant biases may exist, tempering the strength
of their conclusions. To date, there has never been a Randomized Controlled Trial (RCT) that
addresses this question.

This is a non-inferiority RCT at UCDMC to assess differences in LOS, complication rate and
resource utilization between patients randomized to the ICU and a head and neck specialty
ward. Since ICU/Ward bed availability has to be determined before surgery, a subject will be
randomized before surgery when the subject meets all inclusion and none of the exclusion
criteria. Currently, postoperative flap patients who are not enrolled in the study at UCDMC
are monitored in the ICU for a minimum of 24 hours following their surgery.

Inclusion Criteria:

- Patients undergoing free flaps for reconstruction of head and neck surgical defects at
UCDMC, including but not limited to, head and neck cancer defects, osteoradionecrosis
(ORN), and trauma

- 18 years of age and older and able to consent

Exclusion Criteria:

- Vulnerable populations: adults unable to consent, individuals who are not yet adults
(infants, children, teenagers), pregnant women, and prisoners