Comparison of Electric Heating Pad Versus Forced-air Warming to Prevent Inadvertent Perioperative Hypothermia

Comparison of Electric Heating Pad Versus Forced-air Warming to Prevent Inadvertent Perioperative Hypothermia: A Randomized Controlled Trial

Compare core body temperature after laparoscopic surgery using the forced air heating system versus the WARMTAC® (a carbon fiber electric blanket).

Study Overview

• Status: Recruiting
• Conditions: Hypothermia; Anesthesia; Temperature Change, Body
• Intervention / Treatment: Device: WARMTAC; Device: 3M Bair Hugger

Detailed Description

In order to prevent perioperative hypothermia, we will compare two different heating sistems, one of them is an electric pad made with carbon fiber and the other system is a forced-air blanket. Both of them will be situated under the patient during all the laparoscopic surgey.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mirea Chanza; Phone Number: 0034667550215; Email: mchanza@parcdesalutmar.cat

Study Locations

• Spain
  • Barcelona, Spain, 08029
    • Recruiting
    • Hospital del Mar
    • Contact: LLUIS GALLART GALLEGO; Phone Number: 680986184; Email: lluis@gallart.cat

Participation Criteria

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:

• Patients over 18 years of age at the time of the preoperative visit.
• Patients who will undergo elective laparoscopic surgery
• Patients who sign the informed consent indicating that they have been informed of all relevant aspects of the trial.

Exclusion Criteria:

• Axillary temperature> 37.5ºC
• Active infection
• Dysfunction of the autonomic system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrical heating pad; Electrical heating pad (WARMTAC device). Patients will be randomized to one arm. In this arm, the WARMTAC device will be conected and warmed to 41 degrees before patients lay down.	Device: WARMTAC; Randomization to one of the arms previous to surgery.
Experimental: forced-air warming device; Forced-air warming device (3M device). In this arm, the 3M blanket will be conected to forced-air machine and warmed to 41 degrees before patients lay down.	Device: 3M Bair Hugger; Randomization to one of the arms previous to surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core body temperature	temperatured recorded in esophagus	through study completion, an average of 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescues number	Compare number of rescues required by each system to avoid mild hypothermia	through study completion, an average of 12 months
skin lesions	Detect possible skin complications related to heating	through study completion, an average of 12 months

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Investigators: Principal Investigator: Mireia Chanza, Physician, PsMar

Publications and helpful links

General Publications

• Calvo Vecino JM, Casans Frances R, Ripolles Melchor J, Marin Zaldivar C, Gomez Rios MA, Perez Ferrer A, Zaballos Bustingorri JM, Abad Gurumeta A; Grupo de trabajo de la GPC de Hipotermia Perioperatoria No Intencionada de la SEDAR. Clinical practice guideline. Unintentional perioperative hypothermia. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Dec;65(10):564-588. doi: 10.1016/j.redar.2018.07.006. Epub 2018 Nov 15. English, Spanish.
• Matsuzaki Y, Matsukawa T, Ohki K, Yamamoto Y, Nakamura M, Oshibuchi T. Warming by resistive heating maintains perioperative normothermia as well as forced air heating. Br J Anaesth. 2003 May;90(5):689-91. doi: 10.1093/bja/aeg106.
• Ng V, Lai A, Ho V. Comparison of forced-air warming and electric heating pad for maintenance of body temperature during total knee replacement. Anaesthesia. 2006 Nov;61(11):1100-4. doi: 10.1111/j.1365-2044.2006.04816.x.
• John M, Crook D, Dasari K, Eljelani F, El-Haboby A, Harper CM. Comparison of resistive heating and forced-air warming to prevent inadvertent perioperative hypothermia. Br J Anaesth. 2016 Feb;116(2):249-54. doi: 10.1093/bja/aev412.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypothermia; Body Temperature Changes
• Other Study ID Numbers: 2019-8860-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No