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

NCT ID: NCT04410068

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-23

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Temperature Change, Body Hypothermia; Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

WARMTAC

Intervention Type DEVICE

Randomization to one of the arms previous to surgery.

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.

Group Type EXPERIMENTAL

3M Bair Hugger

Intervention Type DEVICE

Randomization to one of the arms previous to surgery.

Interventions

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WARMTAC

Randomization to one of the arms previous to surgery.

Intervention Type DEVICE

3M Bair Hugger

Randomization to one of the arms previous to surgery.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mireia Chanza, Physician

Role: PRINCIPAL_INVESTIGATOR

PSMar

Locations

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Hospital del Mar

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Mirea Chanza

Role: CONTACT

0034667550215

Facility Contacts

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LLUIS GALLART GALLEGO

Role: primary

680986184

References

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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.

Reference Type BACKGROUND
PMID: 30447894 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12697600 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17042850 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26787794 (View on PubMed)

Other Identifiers

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2019-8860-I

Identifier Type: -

Identifier Source: org_study_id

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