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

Not Applicable

• Conditions: Temperature Change, Body; Hypothermia; Anesthesia
• Interventions: Device: 3M Bair Hugger; Device: WARMTAC

• Registration Number: NCT04410068
• Lead Sponsor: Parc de Salut Mar

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.

Study Timeline

• Study Start: 2019-12-23
• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
forced-air warming device	3M Bair Hugger	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.
Electrical heating pad	WARMTAC	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.

Primary Outcome Measures

Name	Time	Method
Core body temperature	through study completion, an average of 12 months	temperatured recorded in esophagus

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain