Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-02-21 @ 1:20 AM
Study NCT ID:
NCT04483895
Status:
UNKNOWN
Last Update Posted:
2020-07-23
First Post:
2020-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between the Oro-Helical Length Technique and the 7-8-9 Rule in Determination of the Ideal Endotracheal Tube Insertion Depth in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2020-07-21', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the proportion of ETTs in abnormal position for each of both insertion depth prediction methods.', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'the occurrence of pulmonary air leaks during the first 24 hours after intubation, accidental extubation and duration of ventilation.', 'timeFrame': '28 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endotracheal Intubation']}, 'descriptionModule': {'briefSummary': 'This study was conducted on neonates needing intubation; Group A,: the ETT insertion depth was estimated according to the OHL method. Group B,: the ETT insertion depth was estimated according to the 7-8-9 method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Full term and preterm neonates who were admitted to NICU and needing endotracheal intubation for invasive mechanical ventilation or administration of surfactant.\n\n * Delivery room intubations were not included as infants are not routinely weighed prior to resuscitation at our hospital. However, infants intubated in the delivery room who were subsequently intubated in the NICU were eligible for inclusion in our study.\n\nExclusion Criteria:\n\n\\- 1. Major upper or lower airway anomalies. 2. Infants with craniofacial, vertebral anomalies. 3. Significant congenital anomalies including cardiac, abdominal or respiratory.\n\n4\\. Neonates those whose parents declined consent were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04483895', 'briefTitle': 'Comparison Between the Oro-Helical Length Technique and the 7-8-9 Rule in Determination of the Ideal Endotracheal Tube Insertion Depth in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Comparison Between the Oro-Helical Length Technique and the 7-8-9 Rule in Determination of the Ideal Endotracheal Tube Insertion Depth in Neonates', 'orgStudyIdInfo': {'id': 'Maha Abdel-Raouf master thesis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'The OHL method', 'description': 'the ETT insertion depth was estimated according to the OHL method.', 'interventionNames': ['Procedure: Endotracheal tube insertion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'The 7-8-9 method', 'description': 'the ETT insertion depth was estimated according to the 7-8-9 method.', 'interventionNames': ['Procedure: Endotracheal tube insertion']}], 'interventions': [{'name': 'Endotracheal tube insertion', 'type': 'PROCEDURE', 'description': 'ETT was inserted and the depth was estimated by either OHL method or 7-8-9 method', 'armGroupLabels': ['The 7-8-9 method', 'The OHL method']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Dina Mohamed, M.D.', 'role': 'CONTACT', 'email': 'drdodi28@gmail.com', 'phone': '+1112636097'}, {'name': 'Dina Shinkar, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Abeer El-Sakka, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'medicine -Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of pediatrics', 'investigatorFullName': 'Dina Mohamed Mohamed Shinkar', 'investigatorAffiliation': 'Ain Shams University'}}}}