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Optimal Heating Temperature in Major Burns Patients

Primary Purpose

Burns, Thermal Injury, Nurse's Role

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active external overheating with heating plate, Aragonia ® MTC 400
Active external overheating with air blanket, Equator Level 1® de Smiths Medical
Sponsored by
University Rovira i Virgili
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Nursing, energy metabolism, hypothermia, heating, burns, thermoregulation

Eligibility Criteria

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

Inclusion Criteria:

  • Patients over 18 years of age.
  • Patients with thermal burns.
  • Patient with high burn criteria according to ABA:
  • 2nd degree burn
  • Patient 18 - 59 years: SCQ> 20%
  • Patient> 60 years or pathology: SCQ> 10%
  • 3rd degree burn
  • SCQ> 10%
  • Patients on mechanical ventilation

Exclusion Criteria:

  • Sepsis criteria according to ABA.
  • Enzyme debridement application (data within 24 hours).
  • 6 hours after a surgical intervention.
  • After 2 hours after healing burns
  • Patients in hemorrhagic shock

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Active Comparator

    Arm Label

    Passive external overheating

    Active external overheating with heating plate

    Active external overheating with air blanket

    Arm Description

    Passive external overheating in the environmental temperature control adjusted to thermal comfort. Measure during 6 hours with indirect calorimetry

    Combination of passive and active external heating with heating plate Measure during 6 hours with indirect calorimetry

    Combination of passive and active external heating with convective air blanket Measure during 6 hours with indirect calorimetry

    Outcomes

    Primary Outcome Measures

    Metabolic expenditure
    Compare the metabolic expenditure of burned patients according to the heating method between the combination of active and passive external adjusted to thermal comfort versus external passive overheating.

    Secondary Outcome Measures

    Optimal environmental temperature
    Define the optimal environmental temperature according to the characteristics of the patient with a large burn during the acute phase, assigning the available resources.
    Thermal comfort
    Analyze thermal comfort according to heating methods in large burned patients.

    Full Information

    First Posted
    May 6, 2020
    Last Updated
    May 15, 2020
    Sponsor
    University Rovira i Virgili
    Collaborators
    University of Valladolid, Sanidad de Castilla y León
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04396951
    Brief Title
    Optimal Heating Temperature in Major Burns Patients
    Official Title
    Clinical Optimization of Ambient Temperature and Heating Methods in Caring in Major Burns Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    March 1, 2022 (Anticipated)
    Study Completion Date
    October 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Rovira i Virgili
    Collaborators
    University of Valladolid, Sanidad de Castilla y León

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    pre and post intervention quasi-experimental epidemiological study without a control group will be carried out in large burned patients that will evaluate the influence on metabolic expenditure of the inclusion of active external rewarming in the control of body temperature.
    Detailed Description
    the heavily burned patient requires specific care to prevent hypothermia and maintain body temperature. You are at high risk of developing hypothermia in the acute phase due to heat losses from convection, radiation, evaporation, and conduction. After the acute phase, the patient due to physiological mechanisms and the hypermetabolic response mainly demands a temperature close to 38.5ºC, ruling out the infectious focus. According to the authors, environmental temperatures between 28-33ºC are recommended for the care of these patients to decrease energy expenditure. The research carried out has studied the influence of passive external heating (environmental regulation), without including the influence of active external heating (heat blankets, heating plate ...) or the study of the thermal comfort of large burned patients and of professionals who provide them they attend. A pre and post intervention quasi-experimental epidemiological study without a control group will be carried out in large burned patients that will evaluate the influence on metabolic expenditure of the inclusion of active external rewarming in the control of body temperature. Metabolic expenditure will be measured by indirect calorimetry in the usual treatment with passive external rewarming and post-intervention in the combination of passive and active external heating. The combination of passive and active external reheating will previously study the operating temperature in various cases for optimal application, as well as the definition of thermal comfort in the large burn unit. The specific training of the personnel involved in the care of these patients will be required for the application of the evidence-based recommendations and the evaluation of their implementation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burns, Thermal Injury, Nurse's Role
    Keywords
    Nursing, energy metabolism, hypothermia, heating, burns, thermoregulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    A pre and post intervention quasi-experimental epidemiological study without control group, will be carried out in large burned patients that will assess the influence on the metabolic expenditure of the inclusion of active external reheating in the control of the environmental temperature.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Passive external overheating
    Arm Type
    No Intervention
    Arm Description
    Passive external overheating in the environmental temperature control adjusted to thermal comfort. Measure during 6 hours with indirect calorimetry
    Arm Title
    Active external overheating with heating plate
    Arm Type
    Active Comparator
    Arm Description
    Combination of passive and active external heating with heating plate Measure during 6 hours with indirect calorimetry
    Arm Title
    Active external overheating with air blanket
    Arm Type
    Active Comparator
    Arm Description
    Combination of passive and active external heating with convective air blanket Measure during 6 hours with indirect calorimetry
    Intervention Type
    Device
    Intervention Name(s)
    Active external overheating with heating plate, Aragonia ® MTC 400
    Other Intervention Name(s)
    Aspira Medical AB Aragonia ® MTC 400. Certificate CE 0413
    Intervention Description
    It is a heating device that is adjustable in height up to 50 cm from the patient and generates radiant heat at low temperature (up to 39 ◦C) distributed evenly. It is equipped with an adjustable 0-9 potentiometer and has a skin temperature probe as a control and safety mechanism Measure during 6 hours with indirect calorimetry in first week
    Intervention Type
    Device
    Intervention Name(s)
    Active external overheating with air blanket, Equator Level 1® de Smiths Medical
    Other Intervention Name(s)
    Equator Level 1® de Smiths Medical REF EQ-5000. Certificate CE 0473
    Intervention Description
    Composed of a unit that produces hot air and forced air adjustable from 38ºC to 43ºC. Sends hot forced air distributed by tubular blanket that convectively heats the patient by diffusing hot air directed at the patient through the textile pore of the air blanket Measure during 6 hours with indirect calorimetry in first week
    Primary Outcome Measure Information:
    Title
    Metabolic expenditure
    Description
    Compare the metabolic expenditure of burned patients according to the heating method between the combination of active and passive external adjusted to thermal comfort versus external passive overheating.
    Time Frame
    Measure during 6 hours with indirect calorimetry in first recovery week with three heating methods
    Secondary Outcome Measure Information:
    Title
    Optimal environmental temperature
    Description
    Define the optimal environmental temperature according to the characteristics of the patient with a large burn during the acute phase, assigning the available resources.
    Time Frame
    Measure during 6 hours with three heating methods in first recovery week
    Title
    Thermal comfort
    Description
    Analyze thermal comfort according to heating methods in large burned patients.
    Time Frame
    Measure during 6 hours with three heating methods first recovery week
    Other Pre-specified Outcome Measures:
    Title
    Nursing care planning
    Description
    Evaluate the nursing care plan in the thermoregulation of the burned patient according to the standardized nurse taxonomy.
    Time Frame
    Measure Scales during three heating methods in six hours, first recovery week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients over 18 years of age. Patients with thermal burns. Patient with high burn criteria according to ABA: 2nd degree burn Patient 18 - 59 years: SCQ> 20% Patient> 60 years or pathology: SCQ> 10% 3rd degree burn SCQ> 10% Patients on mechanical ventilation Exclusion Criteria: Sepsis criteria according to ABA. Enzyme debridement application (data within 24 hours). 6 hours after a surgical intervention. After 2 hours after healing burns Patients in hemorrhagic shock
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Juan Manuel Alonso Fernández, MSN
    Phone
    0034679660502
    Email
    jmalonsof@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juan Manuel Alonso Fernández, MSN
    Organizational Affiliation
    Sanidad Castilla y León
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Optimal Heating Temperature in Major Burns Patients

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