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Study to Evaluate Safety and Efficacy of Blanket Used to Prevent Anesthesia Induced Hypothermia

Primary Purpose

Anesthesia Induced Hypothermia, Inadvertent Perioperative Hypothermia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BARRIER® EasyWarm Active Self-Warming Blanket
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia Induced Hypothermia

Eligibility Criteria

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

Inclusion Criteria:

  1. Gender: Both men and women are included into the study
  2. Subjects' age: Subjects must be at least 18 years old to be included into the study
  3. Type of anaesthesia: Only subjects receiving general anaesthesia are included into the study

  4. Type of surgery: Subjects undergoing only the following three types of surgical procedures (i.e. inclusive of laparoscopic procedures) are included into the study:

    • Gynaecological
    • Orthopaedic
    • Ear, nose and throat (ENT)
  5. Length of surgery: Subjects scheduled for a surgery with a minimum length of 30 minutes and maximum length of 120 minutes
  6. Temperature: Subjects should have a tympanic temperature measurement equal to or greater than 36.0 degrees Celsius when first measured in the preoperative setting the same day as the surgical procedure and before randomisation
  7. Informed Consent Form (ICF): The subject must be able to understand and sign an ICF
  8. Method of temperature assessment: The subject must be able to receive temperature assessments via a tympanic thermometer
  9. Preoperative warming: Subject's scheduled surgical procedure must allow time to be warmed with a fully activated study Investigational Device (ID), at least 30 minutes prior to induction of general anaesthesia
  10. Follow up: The subject must be able to complete a health outcomes questionnaire for follow up 24 hours (+/- 6 hours) after removal of the ID

Exclusion Criteria:

  1. American Society of Anesthesiologists (ASA) Physical Status Classification rating: Subjects with a ASA rating of 4 or greater are excluded from the study
  2. Comorbidity: Known Diabetes with an HbA1c of more than 6 %
  3. Temperature: Subjects with a tympanic temperature measurement below 36.0 degrees Celsius taken in the preoperative setting

  4. Medical history: Subject reports relevant medical history (e.g., neuropathy, peripheral vascular disease, or other) that presents risk to/of:

    1. The subject's normal temperature regulation or
    2. Perception of external temperature or
    3. Subcutaneous lipoatrophy

  5. Medication: 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 Clinical Investigation Plan with Integrated Amendments 01 and 02, MD12-001, final, 14-Jan-2013 5(32)
    3. Subcutaneous lipoatrophy or
    4. All locoregional and neuroaxial blocks

  6. Other:

    1. Presence of skin and soft tissue disorders in areas covered directly by the ID (e.g., pressure ulcers, clinically significant psoriasis, dermatitis or any other interruption of skin integrity that would be affected by direct heat)
    2. Known pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Active warming

    Control

    Arm Description

    BARRIER® EasyWarm Active Self-Warming Blanket

    no active warming, standard of care

    Outcomes

    Primary Outcome Measures

    The Difference in the Arithmetic Mean of Core Body Temperature Measurements During the Perioperative Phase Between the Interventional Treatment Group and the Control Treatment Group
    The subject's core body temperature at any time point is approximated by the arithmetic mean of three repeated tympanic temperature measurements every 15 minutes during the perioperative period

    Secondary Outcome Measures

    Full Information

    First Posted
    July 8, 2013
    Last Updated
    April 21, 2015
    Sponsor
    Molnlycke Health Care AB
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01900067
    Brief Title
    Study to Evaluate Safety and Efficacy of Blanket Used to Prevent Anesthesia Induced Hypothermia
    Official Title
    An Open-Label, Multicenter, Randomised, Controlled Study to Evaluate the Efficacy and Safety of the BARRIER® EasyWarm Active Self-Warming Blanket Used for Continuous Active Warming to Prevent General Anaesthesia Induced Hypothermia During the Perioperative Surgical Period
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    March 2013 (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
    The investigation was designed as an Open-Label, Multicenter, Randomised, Controlled Investigation to Evaluate the Efficacy and Safety of the BARRIER® EasyWarm Active Self-Warming Blanket Used for Continuous Active Warming to Prevent General Anaesthesia Induced Hypothermia During the Perioperative Surgical Period. Null hypothesis (H0): There is no difference between the two study populations (interventional treatment group versus control treatment group) regarding the average of core body temperature measurements during the perioperative phase.Alternative hypothesis (H1): The average of core body temperature measurements during the perioperative phase is significantly higher in the interventional group compared to that of the control group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anesthesia Induced Hypothermia, Inadvertent Perioperative Hypothermia

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Active warming
    Arm Type
    Active Comparator
    Arm Description
    BARRIER® EasyWarm Active Self-Warming Blanket
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    no active warming, standard of care
    Intervention Type
    Device
    Intervention Name(s)
    BARRIER® EasyWarm Active Self-Warming Blanket
    Other Intervention Name(s)
    active warming
    Primary Outcome Measure Information:
    Title
    The Difference in the Arithmetic Mean of Core Body Temperature Measurements During the Perioperative Phase Between the Interventional Treatment Group and the Control Treatment Group
    Description
    The subject's core body temperature at any time point is approximated by the arithmetic mean of three repeated tympanic temperature measurements every 15 minutes during the perioperative period
    Time Frame
    temperature measurments during pre,-intra and postoperative period, on average 1-5 hours, depending on the surgical intervention.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Gender: Both men and women are included into the study Subjects' age: Subjects must be at least 18 years old to be included into the study Type of anaesthesia: Only subjects receiving general anaesthesia are included into the study Type of surgery: Subjects undergoing only the following three types of surgical procedures (i.e. inclusive of laparoscopic procedures) are included into the study: Gynaecological Orthopaedic Ear, nose and throat (ENT) Length of surgery: Subjects scheduled for a surgery with a minimum length of 30 minutes and maximum length of 120 minutes Temperature: Subjects should have a tympanic temperature measurement equal to or greater than 36.0 degrees Celsius when first measured in the preoperative setting the same day as the surgical procedure and before randomisation Informed Consent Form (ICF): The subject must be able to understand and sign an ICF Method of temperature assessment: The subject must be able to receive temperature assessments via a tympanic thermometer Preoperative warming: Subject's scheduled surgical procedure must allow time to be warmed with a fully activated study Investigational Device (ID), at least 30 minutes prior to induction of general anaesthesia Follow up: The subject must be able to complete a health outcomes questionnaire for follow up 24 hours (+/- 6 hours) after removal of the ID Exclusion Criteria: American Society of Anesthesiologists (ASA) Physical Status Classification rating: Subjects with a ASA rating of 4 or greater are excluded from the study Comorbidity: Known Diabetes with an HbA1c of more than 6 % Temperature: Subjects with a tympanic temperature measurement below 36.0 degrees Celsius taken in the preoperative setting Medical history: Subject reports relevant medical history (e.g., neuropathy, peripheral vascular disease, or other) that presents risk to/of: The subject's normal temperature regulation or Perception of external temperature or Subcutaneous lipoatrophy Medication: Current use of concomitant medications that present relevant risk to/of: The subject's normal temperature regulation or Perception of external temperature or Clinical Investigation Plan with Integrated Amendments 01 and 02, MD12-001, final, 14-Jan-2013 5(32) Subcutaneous lipoatrophy or All locoregional and neuroaxial blocks Other: Presence of skin and soft tissue disorders in areas covered directly by the ID (e.g., pressure ulcers, clinically significant psoriasis, dermatitis or any other interruption of skin integrity that would be affected by direct heat) Known pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexander Torossian, Prof
    Organizational Affiliation
    Universitätsklinikum Gießen und Marburg
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Johan Raeder, Prof
    Organizational Affiliation
    OUS-Ullevål
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Karin Geertsen, Dr
    Organizational Affiliation
    Hallands sjukhus Varberg
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Bengt Horn af Åminne, Dr
    Organizational Affiliation
    Aleris Specialistvård, Motala
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Elke Van Gerven, Dr
    Organizational Affiliation
    UZ Leuven Gasthuisberg
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Marc Van de Velde, Prof.
    Organizational Affiliation
    UZ Leuven Gasthuisberg
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Study to Evaluate Safety and Efficacy of Blanket Used to Prevent Anesthesia Induced Hypothermia

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