Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-01 @ 6:23 AM
Study NCT ID:
NCT07073105
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2025-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tracheal Ultrasound for Confirmation of ETT Placement in NICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2025-07-06', 'studyFirstSubmitQcDate': '2025-07-17', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time in minutes to receive tracheal ultrasound by trainee neonatologist results for ETT site', 'timeFrame': '24 hours', 'description': 'Time taken from giving order to perform the tracheal ultrasound by trainee neonatologist to receiving the results of the imaging'}, {'measure': 'time in minutes to receive CXR results for ETT site', 'timeFrame': '24 hours', 'description': 'Time taken from giving order to perform chest x ray to receiving the results of the imaging'}, {'measure': 'time in minutes to receive tracheal ultrasound by expert radiologist results for ETT site', 'timeFrame': '24 hours', 'description': 'Time taken from giving order to perform the tracheal ultrasound by expert radiologist to receiving the results of the imaging'}, {'measure': 'reproducibility of results between CXR , expert and trainee tracheal ultrasound', 'timeFrame': '24 hours', 'description': 'Accuracy of the findings of the tracheal ultrasound by expert, trainee and chest x ray for the same patient'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tracheal ultrasound in preterm neonates for ETT confirmation'], 'conditions': ['Preterm Neonates', 'Mechanical Ventilation', 'Endotracheal Tube']}, 'referencesModule': {'references': [{'pmid': '41364152', 'type': 'DERIVED', 'citation': 'Ibrahim MJA, Elbarbary MNED, Yacoub GEE, Abdo MAM. Confirmation and reproducibility of endotracheal tube position by tracheal ultrasonography in preterms: expert versus trainee. Eur J Pediatr. 2025 Dec 9;185(1):2. doi: 10.1007/s00431-025-06626-3.'}]}, 'descriptionModule': {'briefSummary': 'Improper placement of the endotracheal tube during intubation can lead to dangerous complications. It has been reported that chest radiography is the gold standard method for validation of endotracheal tube (ET) position .\n\nThis study will compare the effectiveness of endotracheal tube position obtained by ultrasonography vs that obtained by chest X-ray with two operators an expert and a trainee in preterm neonates.\n\nThis study will work to the extent that the trainee has the ability to do sonar for premature babies with the same efficiency as an ultrasound specialist.', 'detailedDescription': 'neonate in the neonatal intensive care unit (NICU) are intubated for different reasons and most of these patients undergo chest X-rays (CXRs) several times during their ICU admission to confirm endotracheal tube (ETT) placement, monitor severity of cardiopulmonary illness, and detect complications of other indwelling devices Although the amount of radiation exposure is minimal with CXRs, exposure to multiple CXRs in NICU patients, especially in preterm, results in accumulated radiation burden over time. This can lead to tissue damage and is associated with an increased risk of malignancy Tracheal ultrasonography is technique for confirmation of proper endotracheal intubation. Potential advantages include detection of both main stem and esophageal intubation and less time to image availability than CXR and less radiation Point of care ultrasound (POCUS) of the anterior neck is increasingly used by emergency physicians and anesthesiologists to detect endotracheal and esophageal intubation. It is more accurate and faster than physical examination and capnography, with adult meta-analyses reporting that it has sensitivities of 93-98%, specificities of 97-98% We will explore effectiveness and reproducibility of tracheal ultrasonography done by in hospital neonatologist trainee in the technique vs the expert radiologist in determination of ET position.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Less than 35weeks gestational age\n* Invasive mechanical ventilation via ETT.\n\nExclusion Criteria:\n\n* Upper air way anomalies.\n* eligible patients whose care team deemed enrollment will disrupt patient care.'}, 'identificationModule': {'nctId': 'NCT07073105', 'briefTitle': 'Tracheal Ultrasound for Confirmation of ETT Placement in NICU', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Ultrasonography for Confirmation of Endotracheal Tube Placement in Preterm in Neonatal Intensive Care Unit: Expert Versus Trainee', 'orgStudyIdInfo': {'id': 'Tracheal Ultrasound NICU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'confirmation of ETT by CXR', 'description': 'confirmation of ETT site by CXR the gold standard', 'interventionNames': ['Diagnostic Test: Chest x-ray']}, {'type': 'EXPERIMENTAL', 'label': 'ETT site confirmation by trainee tracheal ultrasound', 'description': 'confirmation of ETT site was done by tracheal ultrasound performed by a trainee neonatologist after receiving training for the procedure', 'interventionNames': ['Diagnostic Test: tracheal ultrasound by trainee neonatologist']}, {'type': 'EXPERIMENTAL', 'label': 'ETT site confirmation by expert tracheal ultrasound', 'description': 'confirmation of ETT tube site by expert radiologist performing tracheal ultrasound', 'interventionNames': ['Diagnostic Test: tracheal ultrasound ( expert radiologist)']}], 'interventions': [{'name': 'tracheal ultrasound ( expert radiologist)', 'type': 'DIAGNOSTIC_TEST', 'description': 'tracheal ultrasound, performed by expert radiologist, for preterm neonates for confirmation of ETT site', 'armGroupLabels': ['ETT site confirmation by expert tracheal ultrasound']}, {'name': 'tracheal ultrasound by trainee neonatologist', 'type': 'DIAGNOSTIC_TEST', 'description': 'tracheal ultrasound, performed by trainee neonatologist ( after receiving training for the procedure) , for preterm neonates for confirmation of ETT site', 'armGroupLabels': ['ETT site confirmation by trainee tracheal ultrasound']}, {'name': 'Chest x-ray', 'type': 'DIAGNOSTIC_TEST', 'description': 'chest xray done for confirmation of ETT site', 'armGroupLabels': ['confirmation of ETT by CXR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'mariam ibrahim, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'after publication', 'ipdSharing': 'YES', 'description': 'individual participant data can be shared after publication from the corresponding author upon reasonable request', 'accessCriteria': 'from the coresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of paediatrics and neonatology , Ain shams University', 'investigatorFullName': 'Mariam Ibrahim', 'investigatorAffiliation': 'Ain Shams University'}}}}