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Perioperative Active Warming Techniques in Colorectal Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00913978
Recruitment Status : Terminated (Study terminated due to financial status of sponsor.)
First Posted : June 4, 2009
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Meltem Yilmaz, Northwestern University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Normothermia Device: Group 1: VitaHeat Device: Group 2: Bair Hugger Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Evaluation of Two Perioperative Active Warming Techniques in Maintenance of Normothermia in Colorectal Surgeries
Actual Study Start Date : April 13, 2017
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : December 21, 2018
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1: VitaHeat
Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room.
 Device: Group 1: VitaHeat
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. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
Active Comparator: Group 2: Bair Hugger
Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room.
 Device: Group 2: Bair Hugger
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. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.


Outcome Measures
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Primary Outcome Measures :
  1. The Primary Outcome Measure Will be the Percentage of Intraoperative Time the Participants Body Temperature is Above 36 Degrees Celcius. [ Time Frame: 1 day ]
    The total percent of intraoperative time (time in the operating room) that the body temperature of the participant is above 36 degrees celcius measured using an esophageal temperature probe.


Secondary Outcome Measures :
  1. Post Operative Temperature on Admission to Post Operative Care Unit (PACU) [ Time Frame: Immediately after surgery ]
    Oral temperature in degrees celcius immediately after admission to the PACU after the planned surgical procedure has been completed.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913978


Locations
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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Meltim Yilmaz, M.D. Northwestern University
  Study Documents (Full-Text)

Documents provided by Meltem Yilmaz, Northwestern University:
Study Protocol and Statistical Analysis Plan  [PDF] March 14, 2018

More Information
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Publications:

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Responsible Party: Meltem Yilmaz, Associate Professor in Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT00913978    
Other Study ID Numbers: STU00202644
First Posted: June 4, 2009    Key Record Dates
Results First Posted: January 13, 2020
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Meltem Yilmaz, Northwestern University:
Normothermia
Colorectal Surgery
Bair Huggers
VitaHeat