An Evaluation of the Impact of Perioperative Warming on Maintenance of Normothermia and Outcome After Abdominal Surgery
Recruitment status was Not yet recruiting
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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 |
- The primary outcome the incidence of surgical site infections. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
- 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 |
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| Contact: Meltim Yilmaz, M.D. | 312-926-8373 | meltemyilmaz@hotmail.com |
| United States, Illinois | |
| Northwestern University | Not yet recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Meltim Yilmaz, M.D. 312-926-8373 meltemyilmaz@hotmail.com | |
| Principal Investigator: Meltim Yilmaz, M.D. | |
| Principal Investigator: | Meltim Yilmaz, M.D. | Northwestern University |
More Information
Publications:
| Responsible Party: | Meltem Yilmaz, M.D., Department of Anesthesiology,Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00913978 History of Changes |
| Other Study ID Numbers: | STU00006131 |
| Study First Received: | June 2, 2009 |
| Last Updated: | June 3, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
Normothermia Abdominal Surgery Bair Paws |
ClinicalTrials.gov processed this record on May 21, 2013