Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:42 PM
Study NCT ID:
NCT07428434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Which Rapid Sequence Induction Technique Should be Used in Urgent Surgery in Children?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peri-Intubation Respiratory and Hemodynamic Complications in Children: Classical vs. Modified Rapid Sequence Induction', 'timeFrame': 'From induction of anesthesia to 5 minutes after tracheal intubation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['positive pressure ventilation', 'aspiration', 'desaturation', 'children', 'urgent surgery'], 'conditions': ['Rapid Sequence Induction (RSI)', 'Full Stomach', 'Pediatric']}, 'descriptionModule': {'briefSummary': 'The goal of our study is to compare classical Rapid Sequence Induction (RSI) and modified Rapid Sequence Induction (mRSI) in pediatric patients with a full stomach undergoing urgent surgical procedures. Due to reduced oxygen reserve in children, modified RSI incorporating gentle positive pressure ventilation has been proposed to reduce hypoxemia while maintaining protection against aspiration.', 'detailedDescription': 'This randomized clinical trial compares classical Rapid Sequence Induction (RSI) and modified Rapid Sequence Induction (mRSI) in pediatric patients with a full stomach undergoing urgent surgery. After standardized preoxygenation with 100% FiO₂ for two minutes, patients are randomized to one of two groups. In the classical RSI group, patients receive propofol (3-5 mg/kg) until loss of consciousness followed by succinylcholine (1-2 mg/kg, age-adjusted), and tracheal intubation is performed 30 seconds after induction without positive pressure ventilation. In the modified RSI group, patients receive fentanyl (4 µg/kg) prior to propofol and succinylcholine at the same doses, followed by gentle positive pressure ventilation using the anesthesia machine in inspiratory support mode (inspiratory pressure 10 cmH₂O, PEEP 5 cmH₂O) for 30 seconds before tracheal intubation. Demographic characteristics, type of surgery, heart rate, systolic and mean arterial pressure, oxygen saturation, and peri-intubation complications including aspiration and desaturation (defined as SpO₂ \\< 90%) are recorded and compared between groups to evaluate safety and efficacy of the two induction techniques'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children under 14 years of age with a full stomach, scheduled for urgent surgery under general anesthesia\n\nExclusion Criteria:\n\n* hemodynamic instability'}, 'identificationModule': {'nctId': 'NCT07428434', 'briefTitle': 'Which Rapid Sequence Induction Technique Should be Used in Urgent Surgery in Children?', 'organization': {'class': 'OTHER', 'fullName': 'Tunis University'}, 'officialTitle': 'Which Rapid Sequence Induction Technique Should be Used in Urgent Surgery in Children?', 'orgStudyIdInfo': {'id': '242025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Classical Rapid Sequence Induction group', 'description': 'Patients received propofol (3-5 mg/kg) followed by age-adjusted succinylcholine (1-2 mg/kg), and tracheal intubation was performed 30 seconds later without positive pressure ventilation.', 'interventionNames': ['Other: Classical Rapid Sequence Induction']}, {'type': 'EXPERIMENTAL', 'label': 'Modified Rapid Sequence Induction (mRSI) group', 'description': 'Patients received fentanyl (4 µg/kg) followed by propofol and succinylcholine at the same doses as the RSI group, then underwent 30 seconds of gentle positive pressure ventilation (inspiratory pressure 10 cmH₂O, PEEP 5 cmH₂O) before tracheal intubation.', 'interventionNames': ['Other: Modified Rapid Sequence Induction']}], 'interventions': [{'name': 'Classical Rapid Sequence Induction', 'type': 'OTHER', 'description': 'Patients received propofol (3-5 mg/kg) until loss of consciousness, followed by succinylcholine (1-2 mg/kg, adjusted for age). Tracheal intubation was performed 30 seconds after the completion of induction, without any positive pressure ventilation', 'armGroupLabels': ['Classical Rapid Sequence Induction group']}, {'name': 'Modified Rapid Sequence Induction', 'type': 'OTHER', 'description': 'Patients received fentanyl (4 µg/kg), followed by propofol and succinylcholine at the same doses as in the RSI group. Following induction, patients received gentle positive pressure ventilation using the anesthesia machine in inspiratory support mode (inspiratory pressure: 10 cmH₂O; PEEP: 5 cmH₂O) for 30 seconds before tracheal intubation', 'armGroupLabels': ['Modified Rapid Sequence Induction (mRSI) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2001', 'city': 'Tunis', 'state': 'Bab Saadoun', 'country': 'Tunisia', 'contacts': [{'name': 'Rym Karaborni', 'role': 'CONTACT', 'email': 'karabornirym@gmail.com', 'phone': '0021651870732'}], 'facility': 'Bechir Hamza Children Hospital', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'centralContacts': [{'name': 'Rym Karaborni, Hospital university assistant', 'role': 'CONTACT', 'email': 'karabornirym@gmail.com', 'phone': '0021651870732'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tunis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mehdi Trifa', 'investigatorAffiliation': 'Tunis University'}}}}