Clinical Optimization of Ambient Temperature and Heating Methods in Caring in Major Burns Patients
Phase: NA
Conditions: Burns, Thermal Injury, Nurse's Role
Sponsor: University Rovira i Virgili

 
Clinical Optimization of 
Ambient Temperature and 
Heating Methods in 
Caring in Major Burns 
Patients 
Optimal Heating Temperature in Major Burns Patients 
 
 
MSN Juan Manuel Alonso Fernández  
Universitat Rovira i Virgili 
Sanidad Castilla y León 
Hospital Universitario Rio Hortega Valladolid 
Universidad de Valladolid 
jualonsofern@saludcatillayleon.es 
 
Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) 
Version 1.0 
Marchy, 2020 

Optimal Heating Temperature in Major Burns Patients 
Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF). Version 1.0 
 
MSN Juan Manuel Alonso Fernández 
Universitat Rovira i Virgili / Hospital Universitario Rio Hortega Valladolid /Sanidad Castilla y 
León /Universidad de Valladolid 
 
2 
HeatingBurns01- Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) 
1. 
Material and methods 
6.1 Design, methodology and justification: 
Pre-experimental pre-experimental epidemiological study without control group,  in large burnt 
patients that will evaluate the influence on the metabolic expenditure of the inclusion of active 
external overheating in the control of ambient temperature  adjusted to thermal comfort..  Two 
methods of active external heating, thermal plate and convective air blanket shall be used. 
Metabolic expenditure shall be measured by indirect calorimetry in the usual treatment with 
passive external overheating and post-intervention in the combination of passive and active 
external warming. 
Sand pre-study  thecombination of passive and active external overheating by measuring  the 
operating temperature in various cases for optimal application, as well as the definition of 
thermal comfort in the unit of large burns. In this way,  two  study stages are integrated as shown 
in  Table  5.. 
Table 5: Study stages Clinical optimization of ambient temperature and heating methods in the 
care of the patient large burned according to thermal comfort 
Stage 1 
Stage 2 
Empirical study of operating temperature according to the 
combination of passive and active external heating 
methods for the definition of environmental comfort. 
Quasi-experimental study of large burned patients to study 
the impact on metabolic expenditure of the inclusion of 
active external overheating in environmental temperature 
control 
6.2. Population and sample: 
6.2.1. Target population 
Burnt patients receiving treatment in large burnt units that require heating for the maintenance 
of normothermia and prevention of hypothermia. In 2017, 9186 burn hospitalizations were 
recorded, with a national incidence of 7 cases per 100,000 inhabitants. 
6.2.2. Accessible population 
Patients with thermal burns admitted to the burn unit of the Río Hortega Hospital in Valladolid 
since March 2020 who do not meet exclusion criteria. Sand reached 30 patients admitted in 
2018 for thermal burns. Although the unit, a reference in Castile and León for the care of burn 
patients, serves a population of 2,419.00 inhabitants 

Optimal Heating Temperature in Major Burns Patients 
Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF). Version 1.0 
 
MSN Juan Manuel Alonso Fernández 
Universitat Rovira i Virgili / Hospital Universitario Rio Hortega Valladolid /Sanidad Castilla y 
León /Universidad de Valladolid 
 
3 
6.2.3. Sampling design 
Sampling in the selection of patients shall be per snowball,all participants in the centre shall be 
included until sample saturation or until 18 months  after  the start of the study, in which 
metabolic expenditure will be assessed in all 3 cases: passive external overheating, thermal plate 
overheating and convective air blanket overheating. 
6.2.4. Sample size 
Using the GRANMO sample matingc,  Version 7.12  was calculated for the difference of media 
coupled in energy expenditure at rest of the combination of passive and active external (in two 
methods, by thermal plate and convective air blanket) versus passive external heating. 
Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 34 subjects are 
required to detect a difference equal to or greater than 0.15 units. A standard deviation of 0.3 
is assumed. A 5% tracking loss rate has been estimated. 
The difference expected to be found in the resting metabolic expenditure rate of at least 0.1 
times the GMB. The increase in baseline metabolic expenditure of these patients in studies with 
burned patients was 1.4 times with standard deviation of 0.2 – 0.32 times. The sample will be 
adjusted to the standard deviation values presented in the pilot sample. 
6.2.5. Inclusion criteria 
• 
Patients over the age of 18. 
• 
Patients with thermal burns. 
• 
Patient with high burn criteria according to ABA: 
o 2nd grade burn 
▪ 
Patient 18 – 59 years: SCQ > 20 % 
▪ 
Patient > 60 years or pathology: SCQ > 10 % 
o 3rd degree burn 
▪ 
SCQ > 10 % 
• 
Patients in mechanical ventilation. 
6.2.6 Exclusion criteria 
• 
Sepsis criteria according to ABA. 
• 
Application of debridenenzymatic (data in the next 24 hours). 
• 
6 hours after surgery. 
• 
After 2 hours after healing the burns 

Optimal Heating Temperature in Major Burns Patients 
Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF). Version 1.0 
 
MSN Juan Manuel Alonso Fernández 
Universitat Rovira i Virgili / Hospital Universitario Rio Hortega Valladolid /Sanidad Castilla y 
León /Universidad de Valladolid 
 
4 
• 
Patients in hemorrhagic shock. 
6.3. Variables 
Sociodemographic data will be collected from the patients included in the study: age, sex, days 
of entry into burn unit, early and hospital mortality. Personal background data, 
previouspathologies. Variables about the burn will be included: Body Surface (BSA) in m2, 
Burned Body Surface (SCQ) in m2  and %, Deep Burned Body Surface (SCQP) in %, origin of the 
burn. 
6.3.1. Dependent variables 
At the stage of defining thermal comfort, the variables shall be collected: 
• 
Operating temperature (Dry temperature + radiant temperature) 
• 
Relative humidity 
• 
Air speed 
For the assessment of nutritional data and energy expenditure, the variables will be collected: 
Weight, Height, Ideal Weight, BMI (kg/m2), FiO2, Charlson Index, Nutri- Score, Nutritional 
Biochemistry, Serum Albumin (g/dl). The calculation of theoretical caloric requirements 
(kcal/day) using the Penn State predictive formula and the protein requirements/day (gr/day) 
calculation will be included. 
• 
Metabolic expenditure, calculated by Indirect calorimetry collecting the variables: 
o VCO2: Carbon dioxide production (Avg VCO2, VCO2  hp) 
o VO2: Consumption of O2  (Avg VO2,VO2  HP) 
o RQ: Cociente respiratorio (Avg RQ, Avg EE) 
o EE: Energy expenditure in kcal/d (Avg EE/m2, AVG EE/Kg) 
• 
Body temperature via surface thermometer 
• 
Central temperature recorded by bladder probethermometer, from entry and 
registration c/8h until 7 days after admission. Time recording of temperature during 
heating analysis. 
• 
Calculation of liquid loss estimation. 
The difference of the metabolic state at rest versus the actual one will be categorized by 
qualitative scale. 

Optimal Heating Temperature in Major Burns Patients 
Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF). Version 1.0 
 
MSN Juan Manuel Alonso Fernández 
Universitat Rovira i Virgili / Hospital Universitario Rio Hortega Valladolid /Sanidad Castilla y 
León /Universidad de Valladolid 
 
5 
Due to the critical condition of the patient, the CONFORT scale will be collected for the 
evaluation of sedation and pain in the critical patient. 
For the assessment of the comfort status (NOC 2008) and thermoregulation (NOC 0800) 
according to Thert scale will be carried out in the application of the two heating techniques. 
 
6.3.2. Independent variables 
• 
Passive external heating: Ambient temperature value in oC Programmable ambient 
temperature,  with ambient temperature programming capability in range of  18 to 35 
oC  with accuracy of +-0.1oC, and driven pressure of  +15  Pa.. 
• 
Active external heating: 
• 
By radiant plate: Patient distance, heating level and control temperature on skin. 
Application time. 
o Aspira Medical AB Aragonia thermal plate ® MTC 400 CE 0413 certified. It is a 
height heating device adjustable up to 50 cm from the patient generates radiant 
heat at low temperature (up to 39oC) evenly distributed. It is equipped with an 
adjustable potentiometer of 0- 9 and has a temperature probe on the skin as a 
control and safety mechanism. 
• 
Convective air blanket:  Application start, Heating power level (35-38-43oC). Application 
time 
o Equator Level  1® of  Smiths  Medical  REF EQ-5000, CE 0473 certified,consisting 
of a unit that produces hot air and adjustable forced air from 38oC to 43oC.. It 
sends the hot forced air distributed by tubular blanket that convectively heats 
the patient by spreading the hot air directed towards the patient through the 
textile pore of the air blanket. 
 
• 
Factors that decrease hyper-metabolic response: 
o Blood glucose monitoring. 
o Administration of Glutamine Supplement59. 
o B-blocker drugs: propanolol, oxandrolone... (Dismimuirán  the GMB) 
o Caloric dose of enteral nutrition. (Sufficient,  scarce augmented by the 
6.4. Instruments collecting information 
Climate comfort measurement 

Optimal Heating Temperature in Major Burns Patients 
Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF). Version 1.0 
 
MSN Juan Manuel Alonso Fernández 
Universitat Rovira i Virgili / Hospital Universitario Rio Hortega Valladolid /Sanidad Castilla y 
León /Universidad de Valladolid 
 
6 
Testo® 435 multifunction air conditioning meter, which performs the necessary measurements 
to adjust the ventilation and air conditioning systems75. The different pluggable sensors and 
probes will provide the variables to study:: 
• 
Thermal speed probe: air speed and volumetric flow rate. 
• 
IAQ (Indoor Air Quality) probe to evaluate air quality measures CO2, ambient 
temperature, ambient humidity and absolute pressure. 
• 
Balloon probe to measure thermal radiation 
• 
Temperature probe to measure ambient temperature, indoor temperature and surface 
temperature. Both with measurement accuracy +/- 0.1 oC 
• 
Location of measures 
o At patient bed level: 
• 
4 measurement points and extrapolate the results assuming radiant symmetry 
conditions, would allow to extrapolate results to the entire object area: patient's 
head and trunk and staff positions at the patient's head and trunk height 
• 
2 radiant plate positions: the nearest (50 cm) and 1 meter, distance when the 
worker's position is simulated in the patient's environment. 
• 
At the worker's level: 2 positions, at the bedside and on the patient's trunk 50 
cm from the center of the bed. 
• 
Media of the convective air blanket in the functions of 38o and 43oC, calculating 
temperature, humidity and speed.. 
Calculation of metabolic expenditure by Indirect Calorimetry and Temperature: 
o Carescape R860® of Datex Ohmeda CE certified with the GE Healthcare Adult D-Lite+ 
Spirometry Kit with CE 0537 certification. GE CARESCAPE™, is a fan that has an 
integrated module that can measure the energy expenditure of patients through 
indirect calorimetry76. 
• 
Central temperature: 
o Vesical probe with 16fr MDCON SV temperature sensor registered in Philips Monitor® 
IntelliVue MP5. 
• 
Body temperature: 
o    

Optimal Heating Temperature in Major Burns Patients 
Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF). Version 1.0 
 
MSN Juan Manuel Alonso Fernández 
Universitat Rovira i Virgili / Hospital Universitario Rio Hortega Valladolid /Sanidad Castilla y 
León /Universidad de Valladolid 
 
7 
6.4.1 Data collection sheet 
The study variables will be collected in the Microsoft  Excel database® as seen in  Annex  I.. 
Patients shall be coded with an assigned number that does not permit identification by a specific 
independent sheet intended for this purpose. 
A collection sheet model for data collection will be distributed with explanatory instructions for 
research partners. 
For the collection of sociodemographic data and study variables, it will be necessary to access 
the patient's medical history with the data that are entered into the program and those 
automatically recorded to the Philips Intelli Vue® medical history. 
6.4.2 Data collection 
For the analysis of thermal comfort, the suppliedam biennage temperatureshall be analysed in 
the values: minimum of 25oC, 28oC, 31oC  as shown in Table 6.. . The ambient temperature of 
33oC is obvious, as it is considered that in combination with the elements of active external 
overheating average conditions of 33oC are reached. The graphical representation of the 
measures shall be carried out as represented in  Annexess  IV and V. 
The convective air blanket, by the heating mechanism, an analysis will be carried out,  studying 
the theoretical effect combined with the ambient temperature. 
Sociodemographic and nutritional data of the patient will be collected after acceptance and 
signature of the informed consent that will be collected in the first days after the patient's entry 
into the burn unit. Variables will be collected during the night shift (22:00 to 8:00) because there 
are no scheduled tasks of cures, diagnostic tests or surgical intervention that may alter both the 
care activity in the unit and the alteration of variables to be collected. Data will be collected for 
6 hours from the intervention: evolution of body and central temperature and metabolic 
expenditure calculated in 24 hours. From the third day after the burn, the 3 heating methods 
will be applied to study, on three consecutive nights 
Table 6: Scenario of combination analysis of heating methods 
 
Registration No. 
Ambient temperature 
25oC 
28oC 
31oC 
Thermal plate at 50 cm 
1 
3 
5 
Thermal plate at  100 cm 
2 
4 
6 
Convective air blanket 38oC 
 
Convective air blanket 43oC 
 

Optimal Heating Temperature in Major Burns Patients 
Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF). Version 1.0 
 
MSN Juan Manuel Alonso Fernández 
Universitat Rovira i Virgili / Hospital Universitario Rio Hortega Valladolid /Sanidad Castilla y 
León /Universidad de Valladolid 
 
8 
Night 1: Ambient temperature 32oC 
Night 2: Ambient temperature and combination with thermal plate 
Night 3: Ambient temperature and combination with thermal blanket. 
6.4.3 Pilot test 
A pilot test will be carried out with at least 2 patients to check the proper collection of variables 
and debugging of errors in the collection methods and the adequacy of the heating application 
times and inclusion of the variables. 
6.5. Data analysis 
The values of the temperatures measured in the empirical study, the discrete and absolute 
variables according to descriptive in ranges, maximum and minimum, trend, mean and median 
valuesshall berecorded..  The VMP  and PPI values willbe calculatedthrough the software 
associated with the  Testo® measuring instruments. 
 
A descriptive analysis of the variables obtained shall be carried out. Continuous quantitative 
variables shall be analysed by the Kolmodorov-Smirnov test and described as mean standard 
deviation (DS) in case of normal distribution, or as median and range if the distribution does not 
follow the normal distribution. Qualitative variables shall be described by absolute and relative 
frequencies. A single-rate analysis shall be performed by observing as variables main dependent 
temperature and metabolic expenditure. With a 95% confidence interval (p<0.05) quantitative 
variable means will be contrasted using Student t or Mann-Whitney's U-depending on the 
sample distribution. The Chi-square test for contingency tables and the Fisher test will be used 
to assess association of qualitative variables. 
A logistic regression model may be established based on the results, analyzing the strength of 
association in explanatory and predictive terms. 
IBM SPSS Stadisticssoftware® v.23 will be used for statistical data analysis 
6.6 Ethical Aspects 
Confidentiality and custody of the data collected in the investigation will be ensured by coding 
the participants. A code will be assigned to each participant in a separate file to the data 
collection that will only be accessed by the principal investigator. 

Optimal Heating Temperature in Major Burns Patients 
Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF). Version 1.0 
 
MSN Juan Manuel Alonso Fernández 
Universitat Rovira i Virgili / Hospital Universitario Rio Hortega Valladolid /Sanidad Castilla y 
León /Universidad de Valladolid 
 
9 
The research project is agreed with the principles of bioethics in biomedical research developed 
in the Helsinki Declaration ratified in Fortaleza (Brazil) in 2013 and the Oviedo Convention on 
the Protection of Human Rights and Dignity promoted by the Council of Europe and validated in 
2000 in Spain. 
The information provided to the participants ortheir  representatives in compliance with the 
Biomedical Research Act 14/2007, of July 3,, will be provided through the patient information 
sheet. 
The processing of the data of the study, access, confidentiality and privacy regulated by: Organic 
Law 15/1999, of December 13, Protection of Personal Data, Law 41/2002 of 14 November, basic 
regulation of patient autonomy and rights and obligations in the field of information and clinical 
documentation and updatingof Regulation (EU) 2016/679 of the European Parliament and of 
the Council of 27 April 2016 on the protection of natural persons with regard to the processing 
of personal data and on the free movement of such data. The same,  is declared compliance with 
regulations or regulations that may be ordered later at the beginning of the study. 
In accordance with RD 223/2004, of February 6, the study will be evaluated by the Ethics 
Committee of Research with medicines of the health area Valladolid West assessing the 
methodology, ethical and legal aspect and balance of the risks and benefits in the realization of 
the study. 
6.6.1 Statement of Interest 
The Principal Investigator declares that he/she has no conflict of interest, no contractual 
relationship with the materials or products that are included in the study. 
6.6.2 Informed information and consent sheet 
An information sheet will be provided to participants (or representative if necessary), candidates 
for inclusion in the study informing about the content of the study, their participation and rights 
as reflected in Annex III.. 
Acceptance of participation in the study will be reflected in the informed consent signed by the 
participant or his/her representative under the conditions shown in Annex IV. 
 
 

Optimal Heating Temperature in Major Burns Patients 
Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF). Version 1.0 
 
MSN Juan Manuel Alonso Fernández 
Universitat Rovira i Virgili / Hospital Universitario Rio Hortega Valladolid /Sanidad Castilla y 
León /Universidad de Valladolid 
 
10 
RESEARCH STUDY PARTICIPANT REPORTING SHEET INFORMACIÓN AL 
Burn Unit 
Hospital 
Research Study 
Thermal comfort and clinical optimization of ambient temperature in 
high burned patient care 
Fact Sheet 
 
Version 1.0 
Principal investigator: 
Contact: 
Burn patients need specific care for maintaining body temperature and avoid hypothermia. Due 
to skin loss you have greater heat loss than healthy people. The usual care to treat this heat loss 
is to increase the temperature of the room to decrease the energy expenditure in the production 
of heat.  
It is common for burn patients to have a higher temperature to healthy people, due to 
accelerated metabolism and high energy consumption while at rest. For this reason, high body 
temperature does not have to originate from an infection, so we value other clinical parameters 
and laboratory tests in order to differentiate its origin. 
Studyobjective   
Your nurse's interest is to improve the care provided in the burn unit, knowing the maintenance 
of body temperature and improving the thermal comfort of patients and professionals. Although 
there are studies on environmental temperature and energy metabolism in burnt patients, they 
have not been conducted on the influence of external heating methods using hot blankets or 
thermal plates. 
Intervention to be carried out in the study 
Participation in the study will consist of applying a heating method, using a thermal plate that 
provides infrared heat used in our usual practice, or a warm air blanket also frequently used in 
the prevention of hypothermia in critical or surgical patients. 
Before and after the application of the heating method, metabolic expenditure, which is the 
relationship between energy consumption and energy that the body needs, will be calculated to 
assess whether energy consumption needs decrease with the heating methods applied. To 
perform this calculation you will not need any additional intervention when performing through 
the fan that already provides breathing support. 
 
Common practice Study combining heating methods 
(High Ambient Temperature) (Hot Air Blanket) (Thermal Plate) 

Optimal Heating Temperature in Major Burns Patients 
Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF). Version 1.0 
 
MSN Juan Manuel Alonso Fernández 
Universitat Rovira i Virgili / Hospital Universitario Rio Hortega Valladolid /Sanidad Castilla y 
León /Universidad de Valladolid 
 
11 
R benefits  and benefits  derived from participation in the study 
There is no risk in your participation in the study, as common warming methods are studied in 
the care of patients with burns, this study will assess its application. 
It may not provide direct benefit to the study participant, but it will serve to apply the heating 
methods optimally. Direct monitoring of energy expenditure parameters can guide the 
treatment of nutrition. 
Communication of results 
If you wish you will be provided with the results of the study at the completion of the study.. 
This research project has been approved by the Research Ethics Committee of the reference 
health area, ensuring compliance with the principles of bioethics in research and patient rights. 
This project has requested the scientific endorsement of the Spanish Society of Intensive Nursing 
and Coronary Units in recognition in the training of the specialization in intensive nursing. 
This project will be registered and available at ClinicalTrial.gov,as an ethical commitment to 
patients and the research process. 
Howparticipant in thisstudy is important thatconozca several legal aspects: 
• 
Your participation is entirelyvoluntary, your participation or revocation will not prejudice 
the health care you receive. 
• 
You will not receive any financial or other compensation for your participation in the study. 
• 
Personal data will be processed in accordance with the provisions of the regulations that 
apply, such as Regulation (EU) 2016/679, of 27 April, General for the Protection of Personal 
Data, and its implementing regulations both at national and European level. 
• 
The recorded data will be processed statistically in a coded form. At all times the participant 
will have the right of access, modification, opposition, rectification or cancellation of the 
data deposited in the database when expressly requested. To do this, you must contact the 
lead investigator. The data will be kept under the responsibility of the Principal Investigator 
of the Estudio______________________________________ Likewise, you have the right 
to contact the Data Protection Agency if you are not satisfied. 
• 
The data will be stored indefinitely, which will allow it to be used by the lead researcher's 
group in future research studies related to the line ofwork. 
 
 
 
Copy for the patient 
 

Optimal Heating Temperature in Major Burns Patients 
Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF). Version 1.0 
 
MSN Juan Manuel Alonso Fernández 
Universitat Rovira i Virgili / Hospital Universitario Rio Hortega Valladolid /Sanidad Castilla y 
León /Universidad de Valladolid 
 
12 
Annex III:Patient Informed Consent 
INFORMED CONSENT PARTICIPANT IN RESEARCH STUDY 
 
Research Study 
Thermal comfort and clinical optimization of ambient temperature in 
high burned patient care 
Informed Consent 
 
Version 1.0 
 
_________________________________________________________ 
(participant's first and lastname) 
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
____declaro: 
(name and surname of the representative if applicable)) 
• I have read the information sheet and understood my  participation  in this  study. 
• I have been informed by 
________________________________________________________________________
________________________________________________________________________
____________________________________ 
(name and surname of the researcher)  
 
whom I've been able to ask questionsof. 
• I participate freely and  voluntarily after  receiving the information 
• I acknowledge my participation rights and may withdraw from the studio: 
o Anytime. 
o Without having to explain. 
o No repercussions for my care. 
By signing this document I voluntarily consent to participate in this study and allow access to 
my dataconforms to me and has been given to me on the information sheet.n.  
Date: 
 
 
Signature of the participant or  representative Signature of the Investigator 
___________________________________________                                               _______________________________________ 
(first and last name)                                                      (first and last name) 
 
 
 
 

Optimal Heating Temperature in Major Burns Patients 
Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF). Version 1.0 
 
MSN Juan Manuel Alonso Fernández 
Universitat Rovira i Virgili / Hospital Universitario Rio Hortega Valladolid /Sanidad Castilla y 
León /Universidad de Valladolid 
 
13 
Copy for the patient 
Space reserved for the 
REVOCATION OF CONSENT 
I ______________________________________________________revoco consent to participate in the study. 
(first and last name)  
 
 
Signature: Date:.