Perioperative Active Warming Techniques in Colorectal Surgeries



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:12/27/2017
Start Date:April 13, 2017
End Date:July 2019
Contact:Meltem Yilmaz, M.D.
Email:m-yilmaz@northwestern.edu
Phone:312-695-4310

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A Prospective Randomized Evaluation of Two Perioperative Active Warming Techniques in Maintenance of Normothermia in Colorectal Surgeries

We propose a study in which we compare two intraoperative active warming devices for
maintenance of normothermia in patients undergoing colorectal surgery. A novel underbody
resistive warming mattress (VitaHeat) will be compared to the forced air warming blanket (3M
Bair Hugger) that is currently used in our institution. Our hypothesis is that the underbody
resistive warming mattress will be equally effective as forced air warming in maintaining
normothermia in colorectal surgery.

Stratified randomization will be performed using a computerized randomization table where the
strata will be type of surgery (open vs closed) and the treatment will be forced air blanket
or underbody mattress warming device. This will allow equal groups of both warming devices in
both types of surgery.

Group 1: Patients will receive active warming via a heating mattress (VitaHEAT Medical)
placed on the OR table with two thin sheets between the patient and the device; one covering
the mattress and the other used as the draw sheet as usual practice. The device will be
turned on 10 minutes prior to the patients' arrival to the operating room table. Patients'
upper body will be covered with blankets. To increase skin surface contact with the mattress
any blankets remaining under the patients' chest or head will be removed after intubation and
replaced with a donut.

Group 2: Patients will receive standard forced air warming applied to the upper body and
turned on after the patient is prepped and draped. These warmers will be placed directly in
contact with the skin without any intervening insulation.

Both groups will have IV fluid warmer initiated on arrival to the operating room. The
operating room temperatures will be adjusted to 21°C.

Participation in the study is voluntary. The patients may choose not to enroll in the
research. Patients who choose not to enroll will use the standard forced air warmer.

Preoperative and postoperative temperatures will be measured orally. Intraoperative core and
skin temperatures will be monitored continuously at 1 minute intervals using an esophageal
probe and skin temperature probe using a skin temp probe placed on the great toe and covered
to prevent any contact with the warming devices.

Intraoperative period: The participants temperature will be monitored and documented at
prescribed times.

Postoperative period: The participants will have temperature monitored in the post anesthesia
care area.

Participation in this study will last for 30 days following surgery at which point study
member will call patient for a 2-4 minute phone call.

Inclusion Criteria:

- Patients older than 18 years old undergoing laparoscopic or open colorectal surgical
procedures under general anesthesia.

Exclusion Criteria:

- Any patient who is less than 18 years old.

- Emergent surgery

- Any patient with thyroid problems

- Any patient with preoperative fever

- Any patient who is pregnant

- Any adult patients unable to consent

- Prisoners
We found this trial at
2
sites
303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Meltem Yilmaz, M.D.
Phone: 312-695-4310
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Phone: 312-695-4310
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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