Evaluation of Core Body Temperature When Using Forced Air Warming or an Active Blanket to Prevent Perioperative Hypothermia

Inadvertent Perioperative Hypothermia Clinical Trial

Official title: Evaluation of Perioperative Core Body Temperature When Using Forced Air Warming or BARRIER® EasyWarm to Prevent Inadvertent Perioperative Hypothermia: An Open-label, Randomized Non-inferiority Comparison

Status Completed

Clinical Trial Summary

This investigation is undertaken to investigate if patient warming with BARRIER® EasyWarm active self-warming blanket differs compared to active warming with forced air warming in terms of core body temperature perioperatively.

A non-inferiority, prospective, open-labelled, randomized, parallel investigation.

Randomized subjects will receive active warming with BARRIER® EasyWarm or with forced air warming. All subjects may receive rescue warming if their core temperature falls below 35.5°C. Rescue warming is optional and defined as the institution's standard of care to prevent hypothermia.

The primary purpose is to investigate if there is a clinically relevant difference in core body temperature between the two treatment groups.

A total of 60 subjects will be included in the investigation, i.e. 30 subjects in each treatment group. The number includes a 30% drop-out rate.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypothermia
• Inadvertent Perioperative Hypothermia
• Preoperative Anxiety Experienced by the Patient

• NCT number: NCT02079311
• Study type: Interventional
• Source: Molnlycke Health Care AB
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Completion date: April 2014