Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT05343702
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2022-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Standard rapi̇d Sequential Intubation Protocol With Rocuronium in Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intubation time', 'timeFrame': 'ten minutes', 'description': 'when successful endotracheal intubation is performed after induction'}, {'measure': 'blood pressure systolic and diastolic', 'timeFrame': 'ten minutes', 'description': 'mmhg'}, {'measure': 'heart rate', 'timeFrame': 'ten minutes', 'description': 'beats/minute'}], 'secondaryOutcomes': [{'measure': 'indirect perfusion', 'timeFrame': 'ten minutes', 'description': 'Indirect tissue perfusion interpretation with endtidal carbon dioxide levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rapid Sequence Induction and Intubation', 'Rocuronium'], 'conditions': ['Rapid Sequence Induction and Intubation', 'Rocuronium']}, 'referencesModule': {'references': [{'pmid': '38655998', 'type': 'DERIVED', 'citation': 'Isik NI, Ozhasenekler A, Yildirim C, Sener A, Kahraman FA, Gunaydin GP. Comparison of rocuronium priming vs. standard rapid sequence intubation technique in emergency department patients requiring intubation. Rev Assoc Med Bras (1992). 2024 Apr 22;70(3):e20231029. doi: 10.1590/1806-9282.20231029. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'Airway management and advanced airway management are the issues that are applied every day in emergency services and that the emergency physician should know best. Rapid sequential intubation is one of the most frequently used techniques in advanced airway management. However, anesthetic agents and paralytic agents have some concerns with some side effects. In our study, This study aimed to compare the effect of standard rapid sequential intubation protocol and application of rocuronium priming technique on the procedure time and hemodynamic profile.', 'detailedDescription': 'This study is a prospective, observational and randomized study conducted between 15.07.2021 and 01.12.2021 in Ankara City Hospital Emergency Medicine Clinic, which is a third-level emergency department with approximately 450,000 patient admissions per year. Patients who applied to the emergency department and needed rapid sequential intubation were included in our study. Randomization was done according to the order of arrival of the cases. The demographic characteristics of the patients included in the study and the presence of diabetes mellitus were recorded. Routine rapid sequential intubation was performed in the standard group. In the priming group, 10% of the rocuronium dose was administered approximately 3 minutes before the induction agent. Intubation time, amount of drug used, vital signs before and after intubation, and end tidal carbon dioxide level to confirm intubation were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Our study is a prospective, observational and randomized study conducted between 15.07.2021 and 01.12.2021 in Ankara City Hospital Emergency Medicine Clinic, which is a third-level emergency department with approximately 450,000 patient admissions per year. Patients who applied to the emergency department and needed rapid sequential intubation were included in our study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be over the age of 18\n* Need for advanced airway\n* To give consent or consent to participate in the study consent of relatives of those who are unable to give\n\nExclusion Criteria:\n\n* Have an indication of a crush (rescue) airway\n* Have one of the difficult airway predictor Look, Evaluate, Obstruction, Neck mobility criteria\n* maxillofacial anomaly or trauma\n* detected during laryngoscopy with a cormack-lehane score of 3 and 4 patients\n* Those who have inconveniences in applying ketamine to the clinic of the patient\n* with a rocuronium or ketamine allergy'}, 'identificationModule': {'nctId': 'NCT05343702', 'briefTitle': 'Comparison of Standard rapi̇d Sequential Intubation Protocol With Rocuronium in Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Comparison of Standard rapi̇d Sequential Intubation Protocol With Rocuronium Priming Technique in Patients Registering to the Emergency Department and With Indication of Elective Intubation', 'orgStudyIdInfo': {'id': 'nısık'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'standard', 'description': 'standard rapid sequence intubation group (paralysis following induction)'}, {'label': 'priming', 'description': 'group primed with rocuronium before induction', 'interventionNames': ['Drug: priming with rocuronium']}], 'interventions': [{'name': 'priming with rocuronium', 'type': 'DRUG', 'description': 'Following induction (paralysis after onset of the induction effect) in routine rapid sequence intubation protocols While paralysis is applied, it is aimed to shorten the half-life of rocuronium by administering a subparalytic dose of rocuronium approximately 3-5 minutes before induction in the priming technique', 'armGroupLabels': ['priming']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0600', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Bilkent Şehir Hastanesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'NURULLAH İSHAK IŞIK, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Bilkent'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'emergency medicine specialist', 'investigatorFullName': 'Nurullah İshak Işık', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}