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An Evaluation of the Impact of Perioperative Warming on Maintenance of Normothermia and Outcome After Abdominal Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Meltem Yilmaz, Northwestern University
ClinicalTrials.gov Identifier:
NCT00913978
First received: June 2, 2009
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

Subjects will participate in this study because they are undergoing scheduled abdominal surgery. The usual standard care participants receive in the operating room include maintaining normal temperature during planned surgical procedure. The anesthesiologist and staff will use warm blankets, warm air and warmed intravenous fluids (fluid given into the patient's IV). This study will evaluate the timing of applying warming devices and evaluating whether there is a difference between the timing and the patient's post operative recovery. Maintaining normothermia in this group of patients will lead to a decreased 30 day morbidity and mortality.


Condition Intervention
Normothermia
Other: Warming pre operatively
Other: Warming in OR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Evaluation of the Impact of Perioperative Warming on Maintenance of Normothermia and Outcome After Abdominal Surgery

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • The primary outcome the incidence of surgical site infections. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Return of bowel function and duration of hospital stay will be compared between groups [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Rate of thromboembolic complications, transfusions, and other type of infections. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 380
Arms Assigned Interventions
Active Comparator: Warming techniques pre operatively
The first group will have the warming devices started in the pre operative area. You will receive warm blankets and a full body warm air blanket called the Bair Paws. This device is non experimental and is FDA approved and used within the hospital to keep patients warm. You will have an intravenous catheter (IV is a small plastic flexible hollow tubing) placed by the pre operative care staff. You will then receive warmed IV solution (salt water).You will then have your temperature taken and documented by the staff at various prescribed times.
Other: Warming pre operatively
The first group will have the warming devices started in the pre operative area. You will receive warm blankets and a full body warm air blanket called the Bair Paws. This device is non experimental and is FDA approved and used within the hospital to keep patients warm. You will have an intravenous catheter (IV is a small plastic flexible hollow tubing) placed by the pre operative care staff. You will then receive warmed IV solution (salt water).
Other Name: Bair Paws
Warming in the operating room
The second group will receive the warming devices and warmed IV fluids once they are in the operating room.
Other: Warming in OR
The second group will receive the warming devices and warmed IV fluids once they are in the operating room.
Other Name: Bair Paws

Detailed Description:

Subjects will be randomized into two groups.

The first group will have the warming devices started in the pre operative area. Subjects will receive warm blankets and a full body warm air blanket called the Bair Paws. This device is non experimental and is FDA approved and used within the hospital to keep patients warm. They will then have an intravenous catheter (IV is a small plastic flexible hollow tubing) placed by the pre operative care staff. Then they will receive warmed IV solution (salt water).They will then have their temperature taken and documented by the staff at various prescribed times.

The second group will receive the warming devices and warmed IV fluids after they are in the operating room.

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. Your part in this study will last until you are admitted to your room after surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years old undergoing abdominal surgical procedures.

Exclusion Criteria:

  • Any patient who is less than 18 years old.
  • Patients with a principal diagnosis suggestive of preoperative infectious diseases.
  • Burn patients.
  • Patients with a documented infection prior to the surgical procedure.
  • Patients whose procedure will be performed with the laparoscope.
  • Pregnancy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913978

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Meltim Yilmaz, M.D. Northwestern University
  More Information

Publications:
Responsible Party: Meltem Yilmaz, Associate Professor in Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT00913978     History of Changes
Other Study ID Numbers: STU00006131
Study First Received: June 2, 2009
Last Updated: October 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Normothermia
Abdominal Surgery
Bair Paws

ClinicalTrials.gov processed this record on November 27, 2014