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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04396951
Other study ID # HEATINGBURNS01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date October 1, 2022

Study information

Verified date May 2020
Source University Rovira i Virgili
Contact Juan Manuel Alonso Fernández, MSN
Phone 0034679660502
Email jmalonsof@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 34
Est. completion date October 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University Rovira i Virgili SACyL, University of Valladolid

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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 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
Secondary Thermal comfort Analyze thermal comfort according to heating methods in large burned patients. Measure during 6 hours with three heating methods first recovery week
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