Effects of Active Prewarming in Perioperative Hypothermia in Adults

Not Applicable

Completed

• Conditions: Hypothermia; Anesthesia; Hypothermia Due to Anesthetic; Hypothermia Following Anesthesia; Hypothermia Following Anesthesia, Sequela
• Interventions: Device: Forced air warming devices

• Registration Number: NCT04033900
• Lead Sponsor: RECIO PÉREZ, JESÚS

Brief Summary

This study evaluates the effect of active prewarming on the frequency and duration of perioperative hypothermia. 50% of patients will receive active warming with forced-air devices prior to entering the operating room, and the other 50% will not receive any active heating measures.

Detailed Description

Inadvertent perioperative hypothermia is defined as a body temperature below 36º C during the perioperative period. It occurs as a result of the effects of anesthetic drugs on the regulation of body temperature and exposure to a cold environment.

The main temperature loss during the perioperative period occurs during the first hour after the anesthetic induction as a result of heat redistribution from the central compartment to the peripheral compartment

The most effective strategy to prevent perioperative hypothermia is the use of forced-air warming devices. These devices are usually initiated once the patient enters the operating room. At that time, the patient has already initiated the heat loss by distributing heat from the central to the peripheral compartment to maintain body temperature.

We intend to use forced-air warming devices before the patients is transferred to the operating room in order to preserve the peripheral body temperature. This way the redistribution of heat should be avoided and, therefore, perioperative hypothermia and its harmful effects will be prevented.

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-06-19
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-26
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

Inclusion Criteria

• > 18 years old.
• American Society of Anesthesiologists I-III.
• Undergoing surgery under general or locoregional anesthesia lasting more than 30 minutes.
• General surgery: hernias, cholecystectomies, hepatectomies, intestinal resections, pancreatoduodenectomies ...
• Traumatology and orthopedics: total / partial knee prosthesis, total / partial hip prosthesis, osteosynthesis, removal of material, arthroscopies, hallux valgus, lumbar arthrodesis ...
• Neurosurgery: lumbar arthrodesis, excision of intracranial tumors.
• Gynecology: Hysterectomies, adnexectomies, hysteroscopy ...
• Otorhinolaryngology: septoplasty, nasosinusal endoscopic surgery, tonsillectomies, adenoidectomies, thyroidectomies...
• Thoracic: Pneumonectomies and pulmonary resections, sympathectomies, thoracoscopy ...
• Urology: Bladder transurethral resection , prostate transurethral resection, nephrectomies.
• Maxillofacial: parathyroidectomies, microsurgery ...
• Ability to understand the study, give authorization and collaborate with data collection

Exclusion Criteria

• Local anesthesia or peripheral nerve block.
• Urgent or emergent surgery.
• Cognitive impairment or lack of collaboration of any kind
• Pregnant women undergoing cesarean section.
• Diabetes Mellitus poorly controlled (HbA1c> 6.5-7%)
• Subjects that are under treatment with drugs that interfere with thermoregulation or may cause drug-induced hyperthermia (amphetamines, barbiturates, inhaled gases ...)
• Subjects with burns, pressure ulcers and other surface disturbances that cover the heating devices
• Subjects with screening temperature > 37.5º C.
• Subjects with fever or active infections.
• Subjects with chronic anemia who require periodic transfusions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prewarming	Forced air warming devices	Active warming is allowed prior to surgery with forced-air warming devices

Primary Outcome Measures

Name	Time	Method
Perioperative hypothermia	From 1 hour to 12 hours	Core temperature below 36º C measured with 3M Spot On monitor every 5 minutes from arrival to the pre-surgical area, during surgery and unit discharge to the ward

Secondary Outcome Measures

Name	Time	Method
Hospital stay	From date of Admission in hospital until the date of discharge from hospital, assessed up to 120 days.	Patient´s days keep in hospital, from admission in hospital until discharge from the home
Hypothermia duration	Minutes with core temperature below 36ºC from arrival to the OR unit discharge to postoperative unit, up to 10 hours, whichever came first.	Time of core temperature below 36º C measured every 5 minutes with 3M Spot On monitor from arrival to the surgery room and unit discharge to postoperative unit.
Surgical site infection	1 Month	Follow-up the wound and evaluation of signs and symptoms of surgical site infection from surgery to review for the nurse.
Prewarming duration	From 10 minutes to 1 hour	Time from pre-warming initiation in pre operative area with forced air warming device until transfer to operating theatre.

Trial Locations

Locations (1)

Hospital Universitario de Torrejon; 🇪🇸 Torrejon de ardoz, Madrid, Spain