Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-24 @ 11:31 PM
Study NCT ID:
NCT03733158
Status:
COMPLETED
Last Update Posted:
2019-06-19
First Post:
2018-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flexible Tip Bougie Catheter Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-17', 'studyFirstSubmitDate': '2018-11-05', 'studyFirstSubmitQcDate': '2018-11-05', 'lastUpdatePostDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to intubation', 'timeFrame': '1 day', 'description': 'time from pick up device to the final placement tube in trachea'}], 'secondaryOutcomes': [{'measure': 'success of intubation', 'timeFrame': '1 day', 'description': 'A failed intubation attempt was defined as an attempt in which the trachea was not intubated, or which required more than 120 seconds to perform'}, {'measure': 'Number of optimalization maneuvers', 'timeFrame': '1 day', 'description': 'the number of optimization maneuvers required (re-adjustment of head position, second assistant) to aid endotracheal intubation.'}, {'measure': 'Ease of use', 'timeFrame': '1 day', 'description': 'self-reported percentage the vocal cord visualization. A 100% score is a extremely difficult procedure. A Ease of use score of 1% means that procedure is extremely easy'}, {'measure': 'Dental compression', 'timeFrame': '1 day', 'description': 'An independent observer scored the severity of dental compressions, which was calculated based on the number of audible teeth clicks (0; 1; ≥2) with the Laerdal airway trainer, and based on a grading of pressure of the teeth (none = 0; mild = 1; moderate/serve ≥2) on the Simman®3G simulator. At the end of each scenario, each participant scored the ease of use of each intubation method on a visual analogue scale (VAS; from 0=Extremely Easy to 100=Extremely Difficult).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endotracheal intubation', 'emergency medicine', 'cardiopulmonary resuscitation', 'physician'], 'conditions': ['Emergency Medicine', 'Endotracheal Intubation', 'Cardiopulmonary Arrest']}, 'referencesModule': {'references': [{'pmid': '32312225', 'type': 'DERIVED', 'citation': 'Ruetzler K, Smereka J, Abelairas-Gomez C, Frass M, Dabrowski M, Bialka S, Misiolek H, Plusa T, Robak O, Aniolek O, Ladny JR, Gorczyca D, Ahuja S, Szarpak L. Comparison of the new flexible tip bougie catheter and standard bougie stylet for tracheal intubation by anesthesiologists in different difficult airway scenarios: a randomized crossover trial. BMC Anesthesiol. 2020 Apr 20;20(1):90. doi: 10.1186/s12871-020-01009-7.'}]}, 'descriptionModule': {'briefSummary': 'We, therefore conducted a randomized cross over study to evaluate the usefulness of this new device use by experienced anesthesiologists in several airway manikin scenarios. We hypothesized that in the hands of experienced anesthesiologists the new Flexible Tip Bougie catheter would perform comparably to the standard bougie catheter) in the normal airway scenario. In the difficult airway (both tongue edema, manual in-line stabilization, or cervical collar stabilization), we hypothesized that the new Flexible Tip Bougie catheter would prove superior to the standard Bougie stylet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physicians\n* give voluntary consent to participate in the study\n* none experience in videolaryngoscopy\n* less than 1 year experience in medicine\n\nExclusion Criteria:\n\n* not meet the above criteria\n* wrist or low back diseases'}, 'identificationModule': {'nctId': 'NCT03733158', 'briefTitle': 'Flexible Tip Bougie Catheter Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Lazarski University'}, 'officialTitle': 'Comparison of the New Flexible Tip Bougie Catheter and Standard Bougie Stylet for Tracheal Intubation by Anesthesiologists in Different Difficult Airway Scenarios: a Randomized Crossover Trial', 'orgStudyIdInfo': {'id': 'INT_2018_UL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal airway', 'description': 'intubation in normal aurway condition', 'interventionNames': ['Device: the standard Bougie stylet for difficult intubation', 'Device: The new Flexible Tip Bougie catheter']}, {'type': 'EXPERIMENTAL', 'label': 'Tongue edema', 'description': 'intubation in Tongue edema condition', 'interventionNames': ['Device: the standard Bougie stylet for difficult intubation', 'Device: The new Flexible Tip Bougie catheter']}, {'type': 'EXPERIMENTAL', 'label': 'Pharyngeal obstruction', 'description': 'intubation in Tongue edema condition', 'interventionNames': ['Device: the standard Bougie stylet for difficult intubation', 'Device: The new Flexible Tip Bougie catheter']}, {'type': 'EXPERIMENTAL', 'label': 'Manual cervical inline stabilization', 'description': 'intubation in Manual cervical inline stabilization condition', 'interventionNames': ['Device: the standard Bougie stylet for difficult intubation', 'Device: The new Flexible Tip Bougie catheter']}, {'type': 'EXPERIMENTAL', 'label': 'Cervical collar stabilization', 'description': 'intubation in Cervical collar stabilization condition', 'interventionNames': ['Device: the standard Bougie stylet for difficult intubation', 'Device: The new Flexible Tip Bougie catheter']}, {'type': 'EXPERIMENTAL', 'label': 'Cervical collar stabilization and pharyngeal obstruction', 'description': 'intubation in Cervical collar stabilization and pharyngeal obstruction condition', 'interventionNames': ['Device: the standard Bougie stylet for difficult intubation', 'Device: The new Flexible Tip Bougie catheter']}], 'interventions': [{'name': 'the standard Bougie stylet for difficult intubation', 'type': 'DEVICE', 'description': 'intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter', 'armGroupLabels': ['Cervical collar stabilization', 'Cervical collar stabilization and pharyngeal obstruction', 'Manual cervical inline stabilization', 'Normal airway', 'Pharyngeal obstruction', 'Tongue edema']}, {'name': 'The new Flexible Tip Bougie catheter', 'type': 'DEVICE', 'description': 'intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter', 'armGroupLabels': ['Cervical collar stabilization', 'Cervical collar stabilization and pharyngeal obstruction', 'Manual cervical inline stabilization', 'Normal airway', 'Pharyngeal obstruction', 'Tongue edema']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-662', 'city': 'Warsaw', 'state': 'Masovia', 'country': 'Poland', 'facility': 'Lazarski University', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Lukasz Szarpak, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lazarski University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'data will be available from the main investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lazarski University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}