Overview

This trial is active, not recruiting.

Condition normothermia
Treatments warming pre operatively, warming in or
Sponsor Northwestern University
End date October 2016
Trial size 380 participants
Trial identifier NCT00913978, STU00006131

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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.
warming pre operatively Bair Paws
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)
The second group will receive the warming devices and warmed IV fluids once they are in the operating room.
warming in or Bair Paws
The second group will receive the warming devices and warmed IV fluids once they are in the operating room.

Primary Outcomes

Measure
The primary outcome the incidence of surgical site infections.
time frame: 7 days

Secondary Outcomes

Measure
Return of bowel function and duration of hospital stay will be compared between groups
time frame: 7 days
Rate of thromboembolic complications, transfusions, and other type of infections.
time frame: 7 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Prospective Randomized Evaluation of the Impact of Perioperative Warming on Maintenance of Normothermia and Outcome After Abdominal Surgery
Principal investigator Meltim Yilmaz, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Northwestern University.