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

Primary Purpose

Inadvertent Perioperative Hypothermia, Preoperative Anxiety Experienced by the Patient

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Active self warming blanket
Forced air warming device
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inadvertent Perioperative Hypothermia focused on measuring Patient warming, Active warming, Forced Air Warming, Warming blanket

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum Gießen und Marburg GmbH
  • Ullevål - Oslo Universitetssykehus
  • Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active self-warming blanket

Forced air warming device

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 18, 2014
Last Updated
October 14, 2015
Sponsor
Molnlycke Health Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT02079311
Brief Title
Evaluation of Core Body Temperature When Using Forced Air Warming or an Active Blanket to Prevent Perioperative Hypothermia
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inadvertent Perioperative Hypothermia, Preoperative Anxiety Experienced by the Patient
Keywords
Patient warming, Active warming, Forced Air Warming, Warming blanket

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active self-warming blanket
Arm Type
Experimental
Arm Description
Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase
Arm Title
Forced air warming device
Arm Type
Active Comparator
Arm Description
Active warming with forced air warming (FAW) during the intraoperative phase.
Intervention Type
Device
Intervention Name(s)
Active self warming blanket
Other Intervention Name(s)
BARRIER® EasyWarm
Intervention Description
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
Intervention Name(s)
Forced air warming device
Other Intervention Name(s)
Bair Hugger™, Equator® level 1.
Intervention Description
Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection.
Primary Outcome Measure Information:
Title
The Difference in Core Body Temperature in the Two Treatment Groups.
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Torossian, Prof. MD
Organizational Affiliation
Universitätsklinikum Gießen und Marburg GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Gießen und Marburg GmbH
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Ullevål - Oslo Universitetssykehus
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2SB
Country
United Kingdom

12. IPD Sharing Statement

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

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