Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-02 @ 8:48 AM
Study NCT ID:
NCT02395432
Status:
COMPLETED
Last Update Posted:
2016-10-12
First Post:
2015-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Difficult Airway
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-11', 'studyFirstSubmitDate': '2015-03-09', 'studyFirstSubmitQcDate': '2015-03-17', 'lastUpdatePostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total time of successful intubation', 'timeFrame': 'Time of Orotracheal intubation (TOTI) (up to 1 hour)'}], 'secondaryOutcomes': [{'measure': 'IDS Scale', 'timeFrame': 'TOTI (up to 1 hour)'}, {'measure': 'POGO Score', 'timeFrame': 'TOTI (up to 1 hour)'}, {'measure': 'number of maneuvers', 'timeFrame': 'TOTI (up to 1 hour)'}, {'measure': 'Number of attempts of endotracheal intubation', 'timeFrame': 'TOTI (up to 1 hour)'}, {'measure': 'Position taken by the anesthesiologist during orotracheal intubation', 'timeFrame': 'TOTI (up to 1 hour)'}, {'measure': 'hemodynamic response', 'timeFrame': 'TOTI pre and postintubation (up to 10 minutes)', 'description': 'heart ratio, Arterial pressure'}, {'measure': 'Complications', 'timeFrame': 'TOTI and postintubation (up to 24 hours)', 'description': 'Visual Analogic Scale (0-10)'}, {'measure': 'endotracheal intubation success rate of each device', 'timeFrame': 'TOTI (up to 1 hour)'}, {'measure': 'Degree of satisfaction', 'timeFrame': 'time of postintubation (up to 10 minutes)', 'description': 'Visual Analogic Scale (0-10)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endotracheal Intubation']}, 'referencesModule': {'references': [{'pmid': '16408534', 'type': 'BACKGROUND', 'citation': 'Pearce A. Evaluation of the airway and preparation for difficulty. Best Pract Res Clin Anaesthesiol. 2005 Dec;19(4):559-79. doi: 10.1016/j.bpa.2005.07.004.'}, {'pmid': '9416711', 'type': 'BACKGROUND', 'citation': 'Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.'}, {'pmid': '10522589', 'type': 'BACKGROUND', 'citation': 'Ochroch EA, Hollander JE, Kush S, Shofer FS, Levitan RM. Assessment of laryngeal view: percentage of glottic opening score vs Cormack and Lehane grading. Can J Anaesth. 1999 Oct;46(10):987-90. doi: 10.1007/BF03013137.'}]}, 'descriptionModule': {'briefSummary': 'Endotracheal intubation is usually required to allow unrestricted surgical approach. The Macintosh laryngoscope is the standard method. However in certain situations as difficult airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic intubation is the gold standard in this scenario, however sometimes it is not possible due to failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA, Barcelona, Spain) has been designed specifically for the airway management. However, despite its use in clinical practice, there are no comparative studies regarding direct laryngoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective general anesthesia requiring OTI.\n* Patients duly informed and they have signed the informed consent during the pre-anesthetic consultation, or be sought after due meditation, expressing its consent to the inclusion in the study.\n* Age ≥18 years.\n* ASA I-III.\n* Sufficient intellectual capacity to understand the procedure and equipment used.\n* Predictors of difficult airway (Mallampatti class III or IV; thyromental distance \\<6 cm, sternomental distance \\<12.5 cm, interincisal distance\\<4.0 cm, bite test II or III, cervical mobility \\<90 ° or history of difficult intubation).\n* Thyroid surgery or present pharyngolaryngeal, glottic or cervical pathology\n* BMI \\>30kg / m2\n* Not presenting risk factors for aspiration\n* Not presenting respiratory disease, coronary or cerebral vascular.\n* Do not have a preoperative sore throat\n\nExclusion Criteria:\n\n* Failure to meet the above criteria\n* Pregnancy\n* Allergy to any drug included in the protocol.'}, 'identificationModule': {'nctId': 'NCT02395432', 'briefTitle': 'A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Difficult Airway', 'organization': {'class': 'OTHER', 'fullName': 'Complexo Hospitalario Universitario de A Coruña'}, 'officialTitle': 'A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Difficult Airway: a Randomised, Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'MGR-TT-2015-D1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Totaltrack', 'description': 'OTI with Totaltrack', 'interventionNames': ['Device: orotracheal intubation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Macintosh Laryngoscope', 'description': 'OTI with Macintosh Laryngoscope', 'interventionNames': ['Device: orotracheal intubation']}], 'interventions': [{'name': 'orotracheal intubation', 'type': 'DEVICE', 'armGroupLabels': ['Macintosh Laryngoscope', 'Totaltrack']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15008', 'city': 'A Coruña', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'Manuel Ángel Gómez Ríos', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manuel Ángel Gómez-Ríos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Manuel Ángel Gómez-Ríos', 'investigatorAffiliation': 'Complexo Hospitalario Universitario de A Coruña'}}}}