Clinical trial NCT00913978: Perioperative Active Warming Techniques in Colorectal Surgeries
Official title: A Prospective Randomized Evaluation of Two Perioperative Active Warming Techniques in Maintenance of Normothermia in Colorectal Surgeries
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Normothermia
Keywords: Normothermia
Colorectal Surgery
Bair Huggers
VitaHeat
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-06-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Primary Outcome Measure Will be the Percentage of Intraoperative Time the Participants Body Temperature is Above 36 Degrees Celcius.
timeFrame: 1 day
Secondary outcomes:
measure: Post Operative Temperature on Admission to Post Operative Care Unit (PACU)
timeFrame: Immediately after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Meltim Yilmaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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