Optimal Heating Temperature in Major Burns Patients

Clinical Optimization of Ambient Temperature and Heating Methods in Caring in Major Burns Patients

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.

Study Overview

• Status: Unknown
• Conditions: Burns; Nurse's Role; Thermal Injury
• Intervention / Treatment: Device: Active external overheating with heating plate, Aragonia ® MTC 400; Device: Active external overheating with air blanket, Equator Level 1® de Smiths Medical

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.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Manuel Alonso Fernández, MSN; Phone Number: 0034679660502; Email: jmalonsof@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Passive external overheating; Passive external overheating in the environmental temperature control adjusted to thermal comfort. Measure during 6 hours with indirect calorimetry
Active Comparator: Active external overheating with heating plate; Combination of passive and active external heating with heating plate Measure during 6 hours with indirect calorimetry	Device: Active external overheating with heating plate, Aragonia ® MTC 400; 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; Other Names: Aspira Medical AB Aragonia ® MTC 400. Certificate CE 0413
Active Comparator: Active external overheating with air blanket; Combination of passive and active external heating with convective air blanket Measure during 6 hours with indirect calorimetry	Device: Active external overheating with air blanket, Equator Level 1® de Smiths Medical; 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; Other Names: Equator Level 1® de Smiths Medical REF EQ-5000. Certificate CE 0473

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measure during 6 hours with indirect calorimetry in first recovery week with three heating methods

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measure during 6 hours with three heating methods in first recovery week
Thermal comfort	Analyze thermal comfort according to heating methods in large burned patients.	Measure during 6 hours with three heating methods first recovery week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nursing care planning	Evaluate the nursing care plan in the thermoregulation of the burned patient according to the standardized nurse taxonomy.	Measure Scales during three heating methods in six hours, first recovery week

Collaborators and Investigators

• Sponsor: University Rovira i Virgili
• Collaborators: University of Valladolid; Sanidad de Castilla y León
• Investigators: Principal Investigator: Juan Manuel Alonso Fernández, MSN, Sanidad Castilla y León

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 15, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Nursing; burns; thermoregulation; hypothermia; energy metabolism; heating
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: HEATINGBURNS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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