Goal-Directed Temperature Management During Prolonged Abdominal Surgery

NCT07854704 | Recruiting

• 2 other identifiers: LOKB-TTM-2024-01Protocol N. 9 dated 23.10.2024
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypothermia Following Anesthesia; Intraoperative Complications; Body Temperature Changes; Anesthesia, General

Keywords

perioperative hypothermia; inadvertent perioperative hypothermia; goal-directed temperature management; intravenous fluid warming; forced-air warming; normothermia; abdominal surgery; pilot study; feasibility study

Outcome Measures

Primary Outcomes (1)

• 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.

  At transfer to the intensive care unit, up to 12 hours after skin incision

Secondary Outcomes (14)

• Perioperative axillary temperature

  Before induction of anaesthesia, hourly during surgery, and at admission to the intensive care unit, up to 12 hours

• Perioperative oesophageal temperature

  Hourly from 1 hour after start of surgery until admission to the intensive care unit, up to 12 hours

• Proportion of participants requiring norepinephrine infusion

  Intraoperative period, up to 12 hours

• Time from skin incision to initiation of norepinephrine infusion

  Intraoperative period, up to 12 hours

• Norepinephrine infusion rate

  Intraoperative period, up to 12 hours

Other Outcomes (6)

• Proportion of screened participants who were randomised

  From start of enrolment through study completion, up to 32 months

• Proportion of eligible participants who provided informed consent

  From start of enrolment through study completion, up to 32 months

• Recruitment rate

  From start of enrolment through study completion, up to 32 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Forced-air warming applied through an upper body blanket at an airflow temperature of 37 °C from induction of anaesthesia until the end of surgery, combined with intravenous infusion of balanced crystalloid solutions stored at 23 °C and administered without additional warming.

Device: Forced-air warming; Other: Unwarmed intravenous fluids

Study group

EXPERIMENTAL

Forced-air warming applied through an upper body blanket at an airflow temperature of 37 °C from induction of anaesthesia until the end of surgery, combined with intravenous infusion of the same balanced crystalloid solutions actively warmed to a target temperature of 39 °C by a medical fluid warmer positioned as close as possible to the venous access site.

Device: Forced-air warming; Device: Intravenous fluid warming

Interventions

Forced-air warming DEVICE

Forced-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.

Also known as: WarmTouch WT-5900

Control group; Study group

Intravenous fluid warming DEVICE

Balanced 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.

Also known as: IRIS medical fluid warmer

Study group

Unwarmed intravenous fluids OTHER

Balanced crystalloid solutions stored at an ambient temperature of 23 °C and administered intravenously without additional warming.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Age 18 years or older
• Scheduled abdominal surgery with an expected duration of at least 3 hours

You may not qualify if:

• 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
• Chronic heart failure stage 2 according to the classification of the Russian Society of Cardiology
• Active infection before surgery

Sponsors & Collaborators

• The Leningrad Regional Clinical Hospital: lead
• North-Western State Medical University named after I.I.Mechnikov: collaborator

Study Sites (1)

The Leningrad Regional Clinical Hospital

Saint Petersburg, 194291, Russia

RECRUITING

MeSH Terms

Conditions

Intraoperative Complications; Body Temperature Changes

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Valentin S Kozlov, MD

  The Leningrad Regional Clinical Hospital

  PRINCIPAL INVESTIGATOR

• Ionas S Simutis, MD, Dsc

  North-Western State Medical University named after I.I.Mechnikov

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentin S Kozlov, MD

CONTACT

+7-931-250-79-30; kozlov.vs@47lokb.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Department of Anesthesiology and Intensive Care

Model Details: Two parallel groups; all participants receive forced-air warming, with the study group additionally receiving actively warmed intravenous fluids.

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 2, 2026
• Study Start: November 15, 2024
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months after publication of the main results and ending 3 years thereafter.
• Access Criteria: Requests should be directed to the corresponding author and will be evaluated on the basis of scientific merit. Data will be shared after approval of a proposal and completion of a data access agreement.

Locations

RU (1)