Optimal Heating Temperature in Major Burns Patients
Clinical Optimization of Ambient Temperature and Heating Methods in Caring in Major Burns Patients
1 other identifier
interventional
34
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2020
CompletedFirst Posted
Study publicly available on registry
May 21, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMay 21, 2020
May 1, 2020
1.5 years
May 6, 2020
May 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Optimal environmental temperature
Measure during 6 hours with three heating methods in first recovery week
Thermal comfort
Measure during 6 hours with three heating methods first recovery week
Other Outcomes (1)
Nursing care planning
Measure Scales during three heating methods in six hours, first recovery week
Study Arms (3)
Passive external overheating
NO INTERVENTIONPassive external overheating in the environmental temperature control adjusted to thermal comfort. Measure during 6 hours with indirect calorimetry
Active external overheating with heating plate
ACTIVE COMPARATORCombination of passive and active external heating with heating plate Measure during 6 hours with indirect calorimetry
Active external overheating with air blanket
ACTIVE COMPARATORCombination of passive and active external heating with convective air blanket Measure during 6 hours with indirect calorimetry
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Patients over 18 years of age.
- Patients with thermal burns.
- Patient with high burn criteria according to ABA:
- nd degree burn
- Patient 18 - 59 years: SCQ\> 20%
- Patient\> 60 years or pathology: SCQ\> 10%
- rd degree burn
- SCQ\> 10%
- Patients on mechanical ventilation
You may not qualify if:
- Sepsis criteria according to ABA.
- Enzyme debridement application (data within 24 hours).
- hours after a surgical intervention.
- After 2 hours after healing burns
- Patients in hemorrhagic shock
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Rovira i Virgililead
- University of Valladolidcollaborator
- Sanidad de Castilla y Leóncollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan Manuel Alonso Fernández, MSN
Sanidad Castilla y León
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master of Science in Nursing
Study Record Dates
First Submitted
May 6, 2020
First Posted
May 21, 2020
Study Start
September 1, 2020
Primary Completion
March 1, 2022
Study Completion
October 1, 2022
Last Updated
May 21, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share