Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-07 @ 9:13 PM
Study NCT ID:
NCT06493058
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2024-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extruded the effectıveness of Prone posıtıon ın ınfants evaluatıon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016684', 'term': 'Prone Position'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2024-04-20', 'studyFirstSubmitQcDate': '2024-07-02', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood Values Monitoring Form', 'timeFrame': 'Ekstübasyondan hemen önce ve ekstübasyon sonrası 24. ve 48. saatlerde alındı', 'description': 'Hemoglobin were evaluated.'}, {'measure': 'Blood Values Monitoring Form', 'timeFrame': 'Taken immediately before extubation and at 24 and 48 hours after extubation', 'description': 'Hematocrit were evaluated.'}, {'measure': 'Blood Values Monitoring Form', 'timeFrame': 'Taken immediately before extubation and at 24 and 48 hours after extubation', 'description': 'Leukocyte were evaluated.'}, {'measure': 'Blood Values Monitoring Form', 'timeFrame': 'Taken immediately before extubation and at 24 and 48 hours after extubation', 'description': 'Platelet were evaluated.'}, {'measure': 'Blood Values Monitoring Form', 'timeFrame': 'Taken immediately before extubation and at 24 and 48 hours after extubation', 'description': 'Procalcitonin were evaluated.'}, {'measure': 'Blood Values Monitoring Form', 'timeFrame': 'Taken immediately before extubation and at 24 and 48 hours after extubation', 'description': 'C-reaktif protein were evaluated.'}], 'primaryOutcomes': [{'measure': 'Life Findings Monitoring Form', 'timeFrame': 'Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation', 'description': 'Pulse values were monitored for 48 hours'}, {'measure': 'Life Findings Monitoring Form', 'timeFrame': 'Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation', 'description': 'Saturation values were monitored for 48 hours'}, {'measure': 'Life Findings Monitoring Form', 'timeFrame': 'Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation', 'description': 'Blood pressure values were monitored for 48 hours'}], 'secondaryOutcomes': [{'measure': 'Arterial Blood Gas Monitoring Form', 'timeFrame': 'Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation', 'description': 'After positioning, potansiyel hidrojen in blood were evaluated.'}, {'measure': 'Arterial Blood Gas Monitoring Form', 'timeFrame': 'Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation', 'description': 'After positioning, Partial arterial oxygen pressure, were evaluated.'}, {'measure': 'Arterial Blood Gas Monitoring Form', 'timeFrame': 'Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation', 'description': 'After positioning, Partial arterial carbon dioxide pressure were evaluated.'}, {'measure': 'Arterial Blood Gas Monitoring Form', 'timeFrame': 'Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation', 'description': 'After positioning, Arterial oxygen saturation were evaluated.'}, {'measure': 'Arterial Blood Gas Monitoring Form', 'timeFrame': 'Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation', 'description': 'After positioning, Laktat, were evaluated.'}, {'measure': 'Arterial Blood Gas Monitoring Form', 'timeFrame': 'Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation', 'description': 'After positioning, arterial blood gases were evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Congenital Heart Diseases', 'Extubation', 'Newborn', 'Prone Position'], 'conditions': ['Prone posıtıon']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to determine the effect of prone position on vital signs, arterial blood gases and blood values in 0-1 year old infants extubated after congenital heart surgery. The study was a randomised controlled experimental type study.', 'detailedDescription': 'The sample of the study consisted of 40 infants aged 0-1 year who underwent surgery in the Cardiovascular Surgery Intensive Care Unit of a private hospital.Data collection tools consisted of "Data Collection Form", "Vital Signs Follow-up Form", "Arterial Blood Gas Follow-up Form", "Blood Values Follow-up Form" prepared by the researcher in line with the literature information and some measurement data used in the study (arterial blood sample obtained with the blood gas measurement device used in the NICU and blood gas parameters (PaCO2, pH, PaO2, Lac and SaO2) and bedside monitor).\n\nThe study was conducted in the Cardiovascular Surgery Intensive Care Unit of a private foundation university hospital. Infants between the ages of 0 and 1 year who had undergone congenital heart surgery and were extubated after surgery, who did not have any congenital anomalies of the lungs in addition to congenital heart disease, who did not have any condition that could affect cardiac, circulatory and respiratory functions or prevent positioning were included in the study. The infants to be included in the study were randomly selected to the control and study groups to avoid bias in the study. Which of the experimental or control groups the infants included in the study would be in was determined by using the address "https://www.calculatorsoup.com".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be between 0-1 years old\n* Having congenital heart surgery\n* Endotracheal intubation has been applied\n* Being extubated after congenital heart surgery\n* Obtaining permission from their parents to participate in the study\n\nExclusion Criteria:\n\n* In addition to the diagnosis of congenital heart disease, congenital heart disease of the lungs with any of the anomalies,\n* Position that may affect cardiac, circulatory and respiratory functions or surgical intervention that prevents ECMO (open sternum bone, ECMO support, etc.)\n* Complications developed during the study,\n* Infants whose parents did not agree to participate in the study were included in the study. is not recognised.'}, 'identificationModule': {'nctId': 'NCT06493058', 'briefTitle': 'Extruded the effectıveness of Prone posıtıon ın ınfants evaluatıon', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Evaluatıon of the Effectiveness of the Prone Position in Babies Extubed After Congenital Cardio Surgery', 'orgStudyIdInfo': {'id': 'E-10840098-772.02-3150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'In our study, the babies in the study group were given the supine, right lateral and left lateral positions (12×1), which are used in nursing care practices in the clinic after extubation, in addition to the supine, right lateral and left lateral positions (12×1), the prone position was given twice a day for 2×2 hours twice a day within 48 hours after extubation, with the head on the midline of the neck and the head facing to the right or left side.', 'interventionNames': ['Other: Prone positioning']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Babies in the control group did not receive any treatment.'}], 'interventions': [{'name': 'Prone positioning', 'type': 'OTHER', 'description': 'The babies in the study group were given the supine, right lateral and left lateral positions (12×1), which are used in nursing care practices in the clinic after extubation, in addition to the supine, right lateral and left lateral positions (12×1), the prone position was given twice a day for 2×2 hours twice a day within 48 hours after extubation, with the head on the midline of the neck and the head facing to the right or left side.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34815', 'city': 'Istanbul', 'state': 'Beykoz', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Meidpol University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Aysel Kökcü Doğan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul Meidpol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'aysel kokcudogan', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}