BurnsNCT04396951
Optimal Heating Temperature in Major Burns Patients
A study testing Active external overheating with heating plate, Aragonia ® MTC 400 and Active external overheating with air blanket, Equator Level 1® de Smiths Medical in people with Burns and Thermal Injury, run by University Rovira i Virgili.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Thermal Injury, Nurse's Role
- What is being tested?
- Active external overheating with heating plate, Aragonia ® MTC 400 and Active external overheating with air blanket, Equator Level 1® de Smiths Medical
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Show all 9Show fewer
- 3rd degree burn
- SCQ> 10%
- Patients on mechanical ventilation
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Burns, Thermal Injury, Nurse's Role
- Being tested
- Active external overheating with heating plate, Aragonia ® MTC 400, Active external overheating with air blanket, Equator Level 1® de Smiths Medical
- Keywords
- Nursing, energy metabolism, hypothermia, heating, burns, thermoregulation
- Medical subject headings
- Burns, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active external overheating with heating plate, Aragonia ® MTC 400Device
Also called Aspira Medical AB Aragonia ® MTC 400. Certificate CE 0413
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 MedicalDevice
Also called Equator Level 1® de Smiths Medical REF EQ-5000. Certificate CE 0473
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
| Study group | Role | What they receive |
|---|---|---|
| Passive external overheating | No intervention | Passive 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 comparator | Combination of passive and active external heating with heating plate Measure during 6 hours with indirect calorimetry Receives: Device: Active external overheating with heating plate, Aragonia ® MTC 400 |
| Active external overheating with air blanket | Active comparator | Combination of passive and active external heating with convective air blanket Measure during 6 hours with indirect calorimetry Receives: Device: Active external overheating with air blanket, Equator Level 1® de Smiths Medical |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measure during 6 hours with indirect calorimetry in first recovery week with three heating methods
Secondary outcomes (2)
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.
Measured: 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.
Measured: Measure during 6 hours with three heating methods first recovery week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valladolid, Sanidad de Castilla y León
- Responsible party
- Principal investigator, Alonso Fernández, Juan Manuel, University Rovira i Virgili
- Investigators
- Juan Manuel Alonso Fernández, MSN, Principal investigator, Sanidad Castilla y León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396951
- Sponsor's protocol ID
- HEATINGBURNS01
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Optimization of Ambient Temperature and Heating Methods in Caring in Major Burns Patients
- ClinicalTrials.gov ID
- NCT04396951
- Acronym / sponsor ID
- HEATINGBURNS01
- Conditions
- Burns, Thermal Injury, Nurse's Role
- Keywords
- Nursing, energy metabolism, hypothermia, heating, burns, thermoregulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- University of Valladolid, Sanidad de Castilla y León
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Passive external overheating | No intervention | –Passive 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 comparator | Device: Active external overheating with heating plate, Aragonia ® MTC 400Combination of passive and active external heating with heating plate Measure during 6 hours with indirect calorimetry |
| Active external overheating with air blanket | Active comparator | Device: Active external overheating with air blanket, Equator Level 1® de Smiths MedicalCombination of passive and active external heating with convective air blanket Measure during 6 hours with indirect calorimetry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active external overheating with heating plate, Aragonia ® MTC 400Also: Aspira Medical AB Aragonia ® MTC 400. Certificate CE 0413It 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 | Device | Active external overheating with heating plate |
| Active external overheating with air blanket, Equator Level 1® de Smiths MedicalAlso: Equator Level 1® de Smiths Medical REF EQ-5000. Certificate CE 0473Composed 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 | Device | Active external overheating with air blanket |
Primary outcome
Metabolic expenditure
Time frame: Measure during 6 hours with indirect calorimetry in first recovery week with three heating methods
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.
2 secondary outcomes
Optimal environmental temperature
Time frame: Measure during 6 hours with three heating methods in first recovery week
Thermal comfort
Time frame: Measure during 6 hours with three heating methods first recovery week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Manuel Alonso Fernández, MSN principal investigator
Sanidad Castilla y León
Questions about this trial
What is this clinical trial studying?
A study testing Active external overheating with heating plate, Aragonia ® MTC 400 and Active external overheating with air blanket, Equator Level 1® de Smiths Medical in people with Burns and Thermal Injury, run by University Rovira i Virgili.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Manuel Alonso Fernández, MSN (0034679660502, jmalonsof@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic expenditure (time frame: Measure during 6 hours with indirect calorimetry in first recovery week with three heating methods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.