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

Temperature Change, Body Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04410068
• Other study ID #: 2019-8860-I
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2021
• Source: Parc de Salut Mar
• Contact: Mirea Chanza
• Phone: 0034667550215
• Email: mchanza[@]parcdesalutmar.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Temperature Changes
• Hypothermia
• Hypothermia; Anesthesia
• Temperature Change, Body

Intervention

Device:
• WARMTAC
Randomization to one of the arms previous to surgery.
• 3M Bair Hugger
Randomization to one of the arms previous to surgery.

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Calvo Vecino JM, Casans Francés R, Ripollés Melchor J, Marín Zaldívar C, Gómez Ríos MA, Pérez 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core body temperature	temperatured recorded in esophagus	through study completion, an average of 12 months
Secondary	Rescues number	Compare number of rescues required by each system to avoid mild hypothermia	through study completion, an average of 12 months
Secondary	skin lesions	Detect possible skin complications related to heating	through study completion, an average of 12 months