Clinical trial NCT04396951: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Burns
Thermal Injury
Nurse's Role
Keywords: Nursing
energy metabolism
hypothermia
heating
burns
thermoregulation
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
Collaborators: name: University of Valladolid
name: Sanidad de Castilla y León
First posted: 2020-05-21
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Metabolic expenditure
timeFrame: Measure during 6 hours with indirect calorimetry in first recovery week with three heating methods
Secondary outcomes:
measure: Optimal environmental temperature
timeFrame: Measure during 6 hours with three heating methods in first recovery week
measure: Thermal comfort
timeFrame: Measure during 6 hours with three heating methods first recovery week
Other outcomes:
measure: Nursing care planning
timeFrame: Measure Scales during three heating methods in six hours, first recovery week
Locations:
Study officials:
affiliation: Sanidad Castilla y León
name: Juan Manuel Alonso Fernández, MSN
role: PRINCIPAL_INVESTIGATOR
References: