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

Primary Purpose

Temperature Change, Body, Hypothermia; Anesthesia

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

WARMTAC

3M Bair Hugger

About this trial

This is an interventional prevention trial for Temperature Change, Body

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital del MarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Electrical heating pad

forced-air warming device

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Core body temperature

temperatured recorded in esophagus

Secondary Outcome Measures

Rescues number

Compare number of rescues required by each system to avoid mild hypothermia

skin lesions

Detect possible skin complications related to heating

Full Information

NCT ID

NCT04410068

First Posted

May 18, 2020

Last Updated

October 5, 2021

Sponsor

Parc de Salut Mar

1. Study Identification

Unique Protocol Identification Number

NCT04410068

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 23, 2019 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Parc de Salut Mar

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Temperature Change, Body, Hypothermia; Anesthesia

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Electrical heating pad

Arm Type

Experimental

Arm Description

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.

Arm Title

forced-air warming device

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

WARMTAC

Intervention Description

Randomization to one of the arms previous to surgery.

Intervention Type

Device

Intervention Name(s)

3M Bair Hugger

Intervention Description

Randomization to one of the arms previous to surgery.

Primary Outcome Measure Information:

Title

Core body temperature

Description

temperatured recorded in esophagus

Time Frame

through study completion, an average of 12 months

Secondary Outcome Measure Information:

Title

Rescues number

Description

Compare number of rescues required by each system to avoid mild hypothermia

Time Frame

through study completion, an average of 12 months

Title

skin lesions

Description

Detect possible skin complications related to heating

Time Frame

through study completion, an average of 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mirea Chanza

Phone

0034667550215

mchanza@parcdesalutmar.cat

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mireia Chanza, Physician

Organizational Affiliation

PSMar

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital del Mar

City

Barcelona

ZIP/Postal Code

08029

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

LLUIS GALLART GALLEGO

Phone

680986184

lluis@gallart.cat

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30447894

Citation

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.

Results Reference

background

PubMed Identifier

12697600

Citation

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.

Results Reference

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PubMed Identifier

17042850

Citation

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.

Results Reference

background

PubMed Identifier

26787794

Citation

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.

Results Reference

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

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