During long operations on the abdomen, patients often get cold. Doctors call this perioperative hypothermia. Even a small drop in body temperature can cause problems, such as more bleeding, wound infection, and a longer stay in hospital.
To keep patients warm during surgery, doctors usually blow warm air over the body through a special blanket. However, the fluids that patients receive through a vein during surgery are normally at room temperature. These cool fluids may lower the body temperature from the inside.
This study compares two ways of keeping patients warm during operations on the abdomen that last three hours or longer.
Everyone taking part receives warm air blown over the body. In addition, one group receives fluids into a vein at room temperature, about 23 °C, which is the usual practice. The other group receives the same fluids warmed to 39 °C by a special device just before the fluid enters the vein.
Participants are placed into one of the two groups by chance, like flipping a coin. Because of the nature of the treatment, the doctors caring for the patient know which group the patient is in.
The researchers measure body temperature before, during, and at the end of surgery. They also record blood pressure, the medicines used to support blood pressure, the amount of fluid given, the amount of urine produced, and blood tests taken on the day after surgery.
This is a pilot study. Its main purpose is to find out whether a larger study would be possible. The researchers want to learn how many patients can be enrolled, whether the treatment can be given exactly as planned, and how complete the collected information is. The results will be used to plan a larger study.
Signed written informed consent
Age 18 years or older
Scheduled abdominal surgery with an expected duration of at least 3 hours
Pregnancy or breastfeeding
End-stage chronic somatic disease
Axillary temperature above 37.0 °C before surgery
Documented thermoregulatory disorder of any origin, including disorders due to ongoing infectious or autoimmune disease or traumatic brain injury
Parallel
Forced-air warming
DeviceForced-air warming system with an upper body blanket; airflow temperature set at 37 °C; applied identically in both groups from induction of anaesthesia until the end of surgery.
Intravenous fluid warming
DeviceBalanced crystalloid solutions actively warmed to a target temperature of 39 °C using a medical fluid warmer; the infusion line is placed inside the heating element as close as possible to the venous access site.
Unwarmed intravenous fluids
Other interventionBalanced crystalloid solutions stored at an ambient temperature of 23 °C and administered intravenously without additional warming.
Core body temperature at admission to the intensive care unit
Oesophageal temperature measured at the time of transfer of the participant from the operating room to the intensive care unit, in degrees Celsius.
Perioperative axillary temperature
Axillary temperature measured with a contact thermometer. Measured in degrees Celsius.
Perioperative oesophageal temperature
Core temperature measured with an oesophageal probe. Measured in degrees Celsius.
Proportion of participants requiring norepinephrine infusion
Number of participants who received an intraoperative norepinephrine infusion, divided by the number of participants analysed in the group, expressed as a percentage.
Time from skin incision to initiation of norepinephrine infusion
Interval between skin incision and the start of norepinephrine infusion, assessed only in participants who received norepinephrine. Measured in minutes.
Proportion of screened participants who were randomised
Feasibility outcome. Number of randomised participants divided by the number of patients screened for eligibility, expressed as a percentage.
Proportion of eligible participants who provided informed consent
Feasibility outcome. Number of participants who provided written informed consent divided by the number of patients who met the eligibility criteria, expressed as a percentage.
Recruitment rate
Feasibility outcome. Number of randomised participants per month of enrolment.
Adherence to the allocated intervention
Feasibility outcome. Number of randomised participants who received the allocated intervention in full, divided by the number of randomised participants, expressed as a percentage.
Click on the lead sponsor to view all of their trials.
The Leningrad Regional Clinical Hospital
Lead sponsor
North-Western State Medical University named after I.I.Mechnikov
Collaborator
