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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079311
• Other study ID #: MD13-001
• Status: Completed
• Phase: N/A
• First received: February 18, 2014
• Last updated: October 14, 2015
• Start date: January 2014
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionNorway: Ethics CommitteeUnited Kingdom: Research Ethics Committee
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Gießen und Marburg GmbH	Marburg
Norway	Ullevål - Oslo Universitetssykehus	Oslo
United Kingdom	Royal Hallamshire Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Countries where clinical trial is conducted

Germany,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No