Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2025-12-28 @ 8:06 PM
Study NCT ID:
NCT00948350
Status:
COMPLETED
Last Update Posted:
2015-04-20
First Post:
2009-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthesia for Awake Fiberoptic Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-17', 'studyFirstSubmitDate': '2009-07-27', 'studyFirstSubmitQcDate': '2009-07-28', 'lastUpdatePostDateStruct': {'date': '2015-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patients satisfaction with anesthesia', 'timeFrame': 'up to two weeks after hospital admission', 'description': 'participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}], 'secondaryOutcomes': [{'measure': 'pain after anesthesia', 'timeFrame': 'Change from Baseline in pain after anesthesia at end of hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cervical instability', 'awake intubation', 'laryngeal anesthesia'], 'conditions': ['Intubation']}, 'referencesModule': {'references': [{'pmid': '26086284', 'type': 'DERIVED', 'citation': 'Malcharek MJ, Bartz M, Rogos B, Gunther L, Sablotzki A, Gille J, Schneider G. Comparison of Enk Fibreoptic Atomizer with translaryngeal injection for topical anaesthesia for awake fibreoptic intubation in patients at risk of secondary cervical injury: A randomised controlled trial. Eur J Anaesthesiol. 2015 Sep;32(9):615-23. doi: 10.1097/EJA.0000000000000285.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, comparative, randomized, monocentric, clinical open study, to compare two anesthesia techniques (translaryngeal injection vs. spray as you go) in patients with cervical instability with regard to technical modalities and quality of fiberoptic awake intubation.', 'detailedDescription': 'In patients with cervical instability anesthesia induction and conventional intubation are associated with the risk of neurological harm. Therefore the method of choice for anesthesia induction is the fiberoptic awake intubation. This method allows to place the ventilation tube without movement of the cervical spinal cord. This procedure is very uncomfortable for the patient and needs the application of topic and/or systemic anesthetics.\n\nWith this clinical study we will compare two established techniques for local laryngeal anesthesia with regard to the quality of technical modalities and postoperative outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with cervical instability undergoing elective decompression of cervical spine\n\nExclusion Criteria:\n\n* patient refused participation\n* contraindications for awake intubation techniques (e.g. nasal bleeding, anatomical disorders)\n* patient under alcohol or drugs\n* emergency surgery'}, 'identificationModule': {'nctId': 'NCT00948350', 'briefTitle': 'Anesthesia for Awake Fiberoptic Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Klinikum St. Georg gGmbH'}, 'officialTitle': 'Anesthesia for Awake Fiberoptic Intubation in Patients With Cervical Instability - Comparison of Translaryngeal Injection and "Spray as You go"-Technique', 'orgStudyIdInfo': {'id': 'EK-BR-34/08-1'}, 'secondaryIdInfos': [{'id': 'Stu08/0041'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'translaryngeal injection', 'description': 'translaryngeal injection of local anesthetics before the awake intubation', 'interventionNames': ['Procedure: awake intubation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'spray as you go', 'description': 'local anesthetics are given through the fiberoptic during awake intubation', 'interventionNames': ['Procedure: awake intubation']}], 'interventions': [{'name': 'awake intubation', 'type': 'PROCEDURE', 'description': 'two anesthesia techniques', 'armGroupLabels': ['spray as you go', 'translaryngeal injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04129', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Klinikum St. Georg gGmbH', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Armin R Sablotzki, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinics of Anesthesiology, Critical care and Pain Therapy'}, {'name': 'Michael Malcharek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic of Anesthesiology, Dept. Neuroanesthesia and Neuromonitoring'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinikum St. Georg gGmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Armin Sablotzki, MD', 'investigatorAffiliation': 'Klinikum St. Georg gGmbH'}}}}