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

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.

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Key information

Conditions

Inadvertent Perioperative Hypothermia Preoperative Anxiety Experienced by the Patient

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Gießen und Marburg GmbH, Marburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active self warming blanket

Device

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.

Other names: BARRIER® EasyWarm

Forced air warming device

Device

Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection.

Other names: Bair Hugger™, Equator® level 1.

Primary outcomes

The Difference in Core Body Temperature in the Two Treatment Groups.

Time frame: 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.

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.

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Official study 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

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Mar 5, 2014
Registry last updated: Nov 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed