Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT05480202
Status:
COMPLETED
Last Update Posted:
2022-07-29
First Post:
2022-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Thoracic Block Technique on Atelectasis in Children on Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-27', 'studyFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2022-07-27', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of heart rate and respiratory rate', 'timeFrame': '10 days for each participant', 'description': 'Assessment of change in heart rate and respiratory rate will be carried out by using electro cardiograph electrodes and pulse oximeter.'}, {'measure': 'Assessment of atelectasis in chest x ray', 'timeFrame': '10 days for each participant', 'description': 'Assessment of atelectasis in chest x ray will be carried out by comparing presence, extent and distribution of atelectasis in x ray film before and intervention'}, {'measure': 'Assessment of arterial blood gases test', 'timeFrame': '10 days for each participant', 'description': 'Assessment of change in arterial blood gases test will be carried out by comparing results before and after intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atelectasis', 'Intensive Care Unit', 'Children']}, 'descriptionModule': {'briefSummary': 'Statement of the problem:\n\n• Does the thoracic block technique has effect on atelectasis in Children on Mechanical Ventilation?\n\nNull hypothesis:\n\n• there is effect of thoracic block technique on atelectasis in children on Mechanical ventilation.', 'detailedDescription': 'Subjects:\n\nThe study targets the children from both sexes. Sample size estimation will be carried out to determine the recruited number of children, selected randomly from Cairo University pediatric specialized hospital intensive care units ,Cairo to participate in the study\n\nStudy design:\n\nRandomized controlled clinical trial.\n\nA. Inclusion criteria:\n\n1. age range from 6 months to 4 years .\n2. diagnosed with pneumonia, receiving Mechanical ventilation.\n3. start from second day of admission to intensive care unit.\n4. have unilateral mild to moderate atelectasis according to medical referral .\n5. should be vitally stable during the session.\n\nB. Exclusion criteria:\n\nThe children will be excluded from the study if they had one of the following:\n\n1. medically unstable ( examples: tachycardia and tachypnea).\n2. uncontrolled convulsion.\n3. irritable or moderate to sever pain\n4. rib fracture\n5. pneumothorax\n\nChildren will be assessed by measuring heart rate, respiratory rate, chest x-ray, arterial blood gases,dynamic compliance, oxygen saturation index before and after ten days of receiving intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age range from 6 months to 4 years .\n2. diagnosed with pneumonia, receiving Mechanical ventilation.\n3. start from second day of admission to intensive care unit.\n4. have unilateral mild to moderate atelectasis according to medical referral.\n5. should be vitally stable during the session.\n\nB. Exclusion criteria:\n\nThe children were excluded from the study if they had one of the following:\n\nExclusion Criteria:\n\nThe children were excluded from the study if they had one of the following:\n\n1. medically unstable ( examples: tachycardia and tachypnea).\n2. uncontrolled convulsion.\n3. irritable or moderate to sever pain\n4. rib fracture\n5. pneumothorax'}, 'identificationModule': {'nctId': 'NCT05480202', 'briefTitle': 'Effect of Thoracic Block Technique on Atelectasis in Children on Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Thoracic Block Technique on Atelectasis in Children on Mechanical Ventilation', 'orgStudyIdInfo': {'id': 'P. T. REC/012/003483'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thoracic block technique and designed chest physical therapy program', 'description': 'Manual compression on healthy lung for 20 seconds and rest for 20 seconds, total time 20 minutes and percussion,vibration , postural drainage one session time for 35 minutes every day for ten days', 'interventionNames': ['Other: Thoracic block technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Designed chest physical therapy program', 'description': 'Percussion, vibration and postural drainage for 30 minutes every day for ten days', 'interventionNames': ['Other: Designed chest physical therapy program']}], 'interventions': [{'name': 'Thoracic block technique', 'type': 'OTHER', 'otherNames': ['Technique of insufflation to reverse atelectasis'], 'description': 'Manual compression of the healthy lung during expiration associated with the use of invasive or non invasive mechanical ventilation', 'armGroupLabels': ['Thoracic block technique and designed chest physical therapy program']}, {'name': 'Designed chest physical therapy program', 'type': 'OTHER', 'description': 'Percussion, vibration and postural drainage', 'armGroupLabels': ['Designed chest physical therapy program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Alaa Abdallah', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Scientific researcher', 'investigatorFullName': 'Alaa Abdallah Amin', 'investigatorAffiliation': 'Cairo University'}}}}