Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-09 @ 7:22 AM
Study NCT ID:
NCT03780218
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2018-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Pulmonary Function in Burn Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001239', 'term': 'Inhalation'}], 'ancestors': [{'id': 'D015656', 'term': 'Respiratory Mechanics'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2018-12-17', 'studyFirstSubmitQcDate': '2018-12-17', 'lastUpdatePostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Vital Capacity', 'timeFrame': '15 minutes', 'description': 'is the total amount of air exhaled during the test. After three trial, the best forced vital capacity value is the outcome'}, {'measure': 'Forced Expiratory Volume in 1 Second', 'timeFrame': '15 minutes', 'description': 'Forced Expiratory Volume in 1 Second is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. After three trial, the best FVC value is the outcome.'}, {'measure': 'Forced Expiratory Volume in 1 Second / Forced Vital Capacity', 'timeFrame': '15 minutes', 'description': 'The ratio of Forced Expiratory Volume in 1 Second / Forced Vital Capacity. This formule is calculated by measuring device. After three trial, the best value is the outcome.'}, {'measure': 'Maximal Inspiratory Pressure', 'timeFrame': '15 minutes', 'description': 'is a measure of the strength of inspiratory muscles, primarily the diaphragm. It is obtained by having the patient inhale as strongly as possible against a mouthpiece. After three trial, the best value is the outcome.'}, {'measure': 'Maximal Expiratory Pressure', 'timeFrame': '15 minutes', 'description': 'a measure of the strength of respiratory muscles, obtained by having the patient exhale as strongly as possible against a mouthpiece. After three trial, the best value is the outcome.'}], 'secondaryOutcomes': [{'measure': 'Peak Expiratory Flow', 'timeFrame': '15 minutes', 'description': "Peak Expiratory Flow is a person's maximum speed of expiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe out air. After three trial, the best value is the outcome."}, {'measure': 'forced expiratory flow', 'timeFrame': '15 minutes', 'description': 'Forced expiratory flow is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.'}, {'measure': 'Peripheral strength', 'timeFrame': '15 minutes', 'description': "Peripheral (Grip) strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles"}, {'measure': 'Pain severity', 'timeFrame': '15 minutes', 'description': 'Pain severity was assessed by visual analogue scale. This scale score range from "no pain=0 point " to "worst imaginable pain=10 points" for intensity. Maximum point means worst pain severity.'}, {'measure': 'Functional Exercise Capacity', 'timeFrame': '10 minutes', 'description': 'It was evaluated by six minutes walk test.The 6-min walk test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The distance will be recorded. The higher distance is indicated better exercise capacity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Burn Injury', 'Pulmonary function', 'Respiratory muscle', 'Peripheral muscle'], 'conditions': ['Burns']}, 'referencesModule': {'references': [{'pmid': '31999499', 'type': 'DERIVED', 'citation': 'Ozkal O, Topuz S, Karahan S, Erdem MM, Konan A, Yasti AC. Clinical predictors of pulmonary functions, respiratory/peripheral muscle strength and exercise capacity at discharge in adults with burn injury. Disabil Rehabil. 2021 Oct;43(20):2875-2881. doi: 10.1080/09638288.2020.1720320. Epub 2020 Jan 30.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the pulmonary function, respiratory muscle strength and peripheral muscle strength in patients with burn injury on the week that they will be discharge from the hospital. Healthy subjects will be evaluated for pulmonary function, respiratory muscle strength and peripheral muscle strength.', 'detailedDescription': 'Burn injures have adverse effect on the respiratory system.In addition to burn injury prolonged hospitalization may increase the ratio of respiratory complications. But, there are no information in the literature about pulmonary function, respiratory muscle strength and peripheral muscle strength in patients with burn injury. Especially, when the patients are discharged from the hospital, it is not known whether the patients are at the same level in terms of pulmonary functions respiratory muscle strength and peripheral muscle strength with healthy individuals. This study will assess pulmonary functions respiratory muscle strength and peripheral muscle strength in patients with burn injury compared to healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Experimental group: Patients with burn injury Control Group: Healthy subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a burn injury\n* Treatment by an inpatient\n* able and willing to complete the informed consent process.\n* Control group consists of healthy adults with the similar demographic characteristics as experimental group\n\nExclusion Criteria:\n\n* having a pulmonary system disease\n* having a cardiac system disease\n* to do regular sports for the last three months'}, 'identificationModule': {'nctId': 'NCT03780218', 'briefTitle': 'Evaluation of Pulmonary Function in Burn Injury', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Evaluation of Pulmonary Function and Respiratory Muscle Strength in Patients With Burn Injury.', 'orgStudyIdInfo': {'id': 'GO 18/1110'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental Group:Respiratory function', 'description': 'Patients with burn injury will be included in this study. Their respiratory functions will be evaluated. Pulmonary function test, respiratory muscle strength and peripheral muscle strength will be assessed on the discharge week.', 'interventionNames': ['Other: Respiratory function']}, {'label': 'Control Group:Respiratory function', 'description': 'Healthy subjects will be included in this study.Their respiratory functions will be evaluated. Pulmonary function test, respiratory muscle strength and peripheral muscle strength will be assessed.', 'interventionNames': ['Other: Respiratory function']}], 'interventions': [{'name': 'Respiratory function', 'type': 'OTHER', 'description': "Respiratory function test evaluates the participants' pulmonary function and respiratory muscle strength", 'armGroupLabels': ['Control Group:Respiratory function', 'Experimental Group:Respiratory function']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ozden Ozkal', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Ozden Ozkal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ozden Ozkal', 'investigatorAffiliation': 'Hacettepe University'}}}}