Optimal Heating Temperature in Major Burns Patients

NCT ID: NCT04396951

Last Updated: 2020-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Burns Thermal Injury Nurse's Role

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Passive external overheating

Passive external overheating in the environmental temperature control adjusted to thermal comfort.

Measure during 6 hours with indirect calorimetry

Group Type NO_INTERVENTION

No interventions assigned to this group

Active external overheating with heating plate

Combination of passive and active external heating with heating plate Measure during 6 hours with indirect calorimetry

Group Type ACTIVE_COMPARATOR

Active external overheating with heating plate, Aragonia ® MTC 400

Intervention Type DEVICE

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

Combination of passive and active external heating with convective air blanket Measure during 6 hours with indirect calorimetry

Group Type ACTIVE_COMPARATOR

Active external overheating with air blanket, Equator Level 1® de Smiths Medical

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Aspira Medical AB Aragonia ® MTC 400. Certificate CE 0413 Equator Level 1® de Smiths Medical REF EQ-5000. Certificate CE 0473

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Valladolid

OTHER

Sponsor Role collaborator

Sanidad de Castilla y León

OTHER

Sponsor Role collaborator

University Rovira i Virgili

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alonso Fernández, Juan Manuel

Master of Science in Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Juan Manuel Alonso Fernández, MSN

Role: PRINCIPAL_INVESTIGATOR

Sanidad Castilla y León

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Juan Manuel Alonso Fernández, MSN

Role: CONTACT

0034679660502

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HEATINGBURNS01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Local Warming of Surgical Incisions
NCT01026259 COMPLETED PHASE3