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

NCT ID: NCT02079311

Last Updated: 2015-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-04-30

Brief 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.

Conditions

Inadvertent Perioperative Hypothermia; Preoperative Anxiety Experienced by the Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Active self-warming blanket

Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase

Group Type: EXPERIMENTAL

Active self warming blanket

Intervention Type: 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.

Forced air warming device

Active warming with forced air warming (FAW) during the intraoperative phase.

Group Type: ACTIVE_COMPARATOR

Forced air warming device

Intervention Type: DEVICE

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

Interventions

Active self warming blanket

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.

Intervention Type: DEVICE

Forced air warming device

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

Intervention Type: DEVICE

Other Intervention Names

BARRIER® EasyWarm; Bair Hugger™; Equator® level 1.

Eligibility Criteria

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:

1. The subject's normal temperature regulation or

2. Perception of external temperature or

3. Subcutaneous lipoatrophy

• Current use of concomitant medications that present relevant risk to/of:

1. The subject's normal temperature regulation or

2. Perception of external temperature or

3. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Torossian, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Gießen und Marburg GmbH

Locations

Universitätsklinikum Gießen und Marburg GmbH

Marburg, , Germany

Ullevål - Oslo Universitetssykehus

Oslo, , Norway

Royal Hallamshire Hospital

Sheffield, , United Kingdom

Countries

Germany; Norway; United Kingdom

Other Identifiers

MD13-001

Identifier Type: -

Identifier Source: org_study_id