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
About this trial
This is an interventional treatment trial for Burns focused on measuring Nursing, energy metabolism, hypothermia, heating, burns, thermoregulation
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
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
NCT ID
NCT04396951
First Posted
May 6, 2020
Last Updated
May 15, 2020
Sponsor
University Rovira i Virgili
Collaborators
University of Valladolid, Sanidad de Castilla y León
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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