Effects of Active Prewarming in Perioperative Hypothermia in Adults

July 15, 2021 updated by: RECIO PÉREZ, JESÚS

Effect of Active Warming Prior to Surgery in Perioperative Hypothermia

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

197

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Madrid
      • Torrejon de ardoz, Madrid, Spain, 28850
        • Hospital Universitario de Torrejón

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Prewarming
Active warming is allowed prior to surgery with forced-air warming devices
In the treatment group, heating will be started with a pre-surgical forced-air blanket "Outpatient Warming Blanket model 11101 Bair Hugger from 3M" and a forced-air heating unit "Bair Hugger Warming Unit Model 775 from 3M" at 38-43º C which will be maintain during the stay in the pre-surgery room until the transfer to the operating room
Other Names:
  • Outpatient Warming Blanket Model 11101 Bair Hugger 3M
  • BAir Hugger Warming Unit Model 775 3M
NO_INTERVENTION: No prewarming
Non active warming is allowed before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative hypothermia
Time Frame: 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
From 1 hour to 12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypothermia duration
Time Frame: 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.
Minutes with core temperature below 36ºC from arrival to the OR unit discharge to postoperative unit, up to 10 hours, whichever came first.
Hospital stay
Time Frame: 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
From date of Admission in hospital until the date of discharge from hospital, assessed up to 120 days.
Surgical site infection
Time Frame: 1 Month
Follow-up the wound and evaluation of signs and symptoms of surgical site infection from surgery to review for the nurse.
1 Month
Prewarming duration
Time Frame: 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.
From 10 minutes to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: JESÚS RECIO PÉREZ, ANESTHETIST, Hospital Universitario de Torrejón

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

June 19, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (ACTUAL)

July 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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