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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Inadvertent Perioperative Hypothermia, Preoperative Anxiety Experienced by the Patient

Intervention / Treatment
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* Device: Active self warming blanket
* Device: Forced air warming device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent i.e. subject must be able to understand and sign the Informed Consent Form (ICF) Male and female subjects aged 18 years and over Subject scheduled for surgery with a minimum length of 60 minutes and a maximum length of 120 minutes Scheduled surgery must be performed entirely under general anaesthesia The subject must be able to receive temperature assessments via an oesophageal temperature probe when under general anaesthesia and via an oral thermometer before and after general anaesthesia as well as in the pre- and post-op area The subject must have an oral temperature measurement of at least 36.0°C when first measured in the preoperative setting The subject's scheduled surgical procedure must allow time to be warmed with a fully activated BARRIER® EasyWarm at least 30 minutes prior to induction of general anaesthesia Exclusion Criteria: Subjects with an American Society of Anesthesiologists (ASA) rating of 4 or greater Known Diabetes with an HbA1c of more than 6 % Relevant medical history (e.g., neuropathy, peripheral vascular disease, circulatory disorder or other) that presents risk to/of: The subject's normal temperature regulation or Perception of external temperature or Subcutaneous lipoatrophy Current use of concomitant medications that present relevant risk to/of: The subject's normal temperature regulation or Perception of external temperature or Subcutaneous lipoatrophy Epidural/Spinal anaesthesia An oral temperature measurement ≥ 37.5° Contraindications to the oesophagus temperature probe and oral thermometer Presence of skin and soft tissue disorders in areas covered directly by the device in the two treatment groups (e.g. pressure ulcers, clinically significant psoriasis, dermatitis or any other interruption of skin integrity that would be affected by direct heat) Pregnancy Severe non-compliance to protocol as judged by the investigator and/or Mölnlycke Health Care

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active self-warming blanket<br>Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase | Device: Active self warming blanket<br>* BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron.<br>* Other names: BARRIER® EasyWarm;|
| Active Comparator: Forced air warming device<br>Active warming with forced air warming (FAW) during the intraoperative phase. | Device: Forced air warming device<br>* Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection.<br>* Other names: Equator® level 1.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Difference in Core Body Temperature in the Two Treatment Groups. | Temperature assessments will be made using an oesophageal temperature probe when the subject is under general anaesthesia and by oral thermometer for all other temperature assessments performed in pre-, intra- and post-op. The mean value is calculated on all temperature measured during pre-, intra- and post-op. | Subjects will be followed for one day of hospital stay, data to be collected during the perioperative phase. Expected to be between 5-8 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient warming, Active warming, Forced Air Warming, Warming blanket