Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT04396951
Status:
UNKNOWN
Last Update Posted:
2020-05-21
First Post:
2020-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimal Heating Temperature in Major Burns Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-11', 'size': 495072, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2020-05-15T17:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-15', 'studyFirstSubmitDate': '2020-05-06', 'studyFirstSubmitQcDate': '2020-05-15', 'lastUpdatePostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Nursing care planning', 'timeFrame': 'Measure Scales during three heating methods in six hours, first recovery week', 'description': 'Evaluate the nursing care plan in the thermoregulation of the burned patient according to the standardized nurse taxonomy.'}], 'primaryOutcomes': [{'measure': 'Metabolic expenditure', 'timeFrame': 'Measure during 6 hours with indirect calorimetry in first recovery week with three heating methods', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Optimal environmental temperature', 'timeFrame': 'Measure during 6 hours with three heating methods in first recovery week', 'description': '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': 'Thermal comfort', 'timeFrame': 'Measure during 6 hours with three heating methods first recovery week', 'description': 'Analyze thermal comfort according to heating methods in large burned patients.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nursing', 'energy metabolism', 'hypothermia', 'heating', 'burns', 'thermoregulation'], 'conditions': ['Burns', 'Thermal Injury', "Nurse's Role"]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age.\n* Patients with thermal burns.\n* Patient with high burn criteria according to ABA:\n* 2nd degree burn\n* Patient 18 - 59 years: SCQ\\> 20%\n* Patient\\> 60 years or pathology: SCQ\\> 10%\n* 3rd degree burn\n* SCQ\\> 10%\n* Patients on mechanical ventilation\n\nExclusion Criteria:\n\n* Sepsis criteria according to ABA.\n* Enzyme debridement application (data within 24 hours).\n* 6 hours after a surgical intervention.\n* After 2 hours after healing burns\n* Patients in hemorrhagic shock'}, 'identificationModule': {'nctId': 'NCT04396951', 'briefTitle': 'Optimal Heating Temperature in Major Burns Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Rovira i Virgili'}, 'officialTitle': 'Clinical Optimization of Ambient Temperature and Heating Methods in Caring in Major Burns Patients', 'orgStudyIdInfo': {'id': 'HEATINGBURNS01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Passive external overheating', 'description': 'Passive external overheating in the environmental temperature control adjusted to thermal comfort.\n\nMeasure during 6 hours with indirect calorimetry'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active external overheating with heating plate', 'description': 'Combination of passive and active external heating with heating plate Measure during 6 hours with indirect calorimetry', 'interventionNames': ['Device: Active external overheating with heating plate, Aragonia ® MTC 400']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active external overheating with air blanket', 'description': 'Combination of passive and active external heating with convective air blanket Measure during 6 hours with indirect calorimetry', 'interventionNames': ['Device: Active external overheating with air blanket, Equator Level 1® de Smiths Medical']}], 'interventions': [{'name': 'Active external overheating with heating plate, Aragonia ® MTC 400', 'type': 'DEVICE', 'otherNames': ['Aspira Medical AB Aragonia ® MTC 400. Certificate CE 0413'], 'description': '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', 'armGroupLabels': ['Active external overheating with heating plate']}, {'name': 'Active external overheating with air blanket, Equator Level 1® de Smiths Medical', 'type': 'DEVICE', 'otherNames': ['Equator Level 1® de Smiths Medical REF EQ-5000. Certificate CE 0473'], 'description': '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', 'armGroupLabels': ['Active external overheating with air blanket']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Juan Manuel Alonso Fernández, MSN', 'role': 'CONTACT', 'email': 'jmalonsof@gmail.com', 'phone': '0034679660502'}], 'overallOfficials': [{'name': 'Juan Manuel Alonso Fernández, MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sanidad Castilla y León'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Rovira i Virgili', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Valladolid', 'class': 'OTHER'}, {'name': 'Sanidad de Castilla y León', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master of Science in Nursing', 'investigatorFullName': 'Alonso Fernández, Juan Manuel', 'investigatorAffiliation': 'University Rovira i Virgili'}}}}