Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-16 @ 10:53 AM
Study NCT ID:
NCT01691703
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
2012-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Technique for Difficult Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-19', 'studyFirstSubmitDate': '2012-09-18', 'studyFirstSubmitQcDate': '2012-09-20', 'lastUpdatePostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cormack and Lehane grade achieved when using the combination technique compared with the Cormack and Lehane grade achieved earlier when using the Macintosh (video)laryngoscope alone.', 'timeFrame': 'The patients will be followed during induction of anesthesia, an average of 10 minutes', 'description': 'The operator will score these grades during the process of intubation. Pictures will be taken of the first and the second Cormack and Lehane grade, and these pictures will later be scored by two anaesthesiologists, blinded for the technique used (videolaryngoscopy alone or videolaryngoscopy combined with the Bonfils®).'}], 'secondaryOutcomes': [{'measure': 'Proportion of successful intubation with the 2 methods under study, without the use of adjuncts.', 'timeFrame': 'The patients will be followed during induction of anesthesia, an average of 10 minutes', 'description': 'Proportion of successful intubation with the 2 methods under study, without the use of adjuncts.'}, {'measure': 'Time until successful endotracheal intubation', 'timeFrame': 'The patients will be followed during induction of anesthesia, an average of maximal 3 minutes', 'description': 'Time until successful endotracheal intubation will be defined as the time from the moment the blade of the Macintosh videolaryngoscope is placed between the teeth until the time the anaesthesiologist confirms the endotracheal tube to be in the trachea.'}, {'measure': 'Complications rendered on during the procedure', 'timeFrame': 'The patients will be followed during induction of anesthesia, an average of 10 minutes', 'description': 'Complications that will be recorded are: trauma to the oral cavity (defined as any amount of bright red blood in the oral cavity), dental trauma, and regurgitation seen by the anaesthesiologist. Also oxygen saturation (SpO2) at the end of the procedure will be noted, a saturation of less than 90% will be defined as hypoxia.'}, {'measure': 'Adjuncts being used', 'timeFrame': 'The patients will be followed during induction of anesthesia, an average of 10 minutes', 'description': 'Adjuncts that can be used are: gum elastic bougie, stylet and the BURP manoeuvre (performed by a second operator).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fiber Optic Technology/methods', 'Intubation, Intratracheal/methods', 'Laryngoscopy/methods'], 'conditions': ['Intubation; Difficult', 'Failed or Difficult Intubation', 'Failed or Difficult Intubation, Initial Encounter', 'Anesthesia Intubation Complication']}, 'referencesModule': {'references': [{'pmid': '22250284', 'type': 'BACKGROUND', 'citation': 'Van Zundert AA, Pieters BM. Combined technique using videolaryngoscopy and Bonfils for a difficult airway intubation. Br J Anaesth. 2012 Feb;108(2):327-8. doi: 10.1093/bja/aer471. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'A difficult tracheal intubation can be a problem, even if one has taken all precautions. A possible solution can be using a videolaryngoscope in conjunct with the Bonfils® intubation scope. As such, the videolaryngoscope can be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® intubation scope.', 'detailedDescription': 'In this blinded, unrandomised trial the investigators would like to investigate the change in Cormack and Lehane grade when using both videolaryngoscope (Macintosh videolaryngoscope, Karl Storz, Tuttlingen, Germany) and Bonfils® (Karl Storz, Tuttlingen, Germany). They also want to record the success of intubation and the time needed until successful endotracheal intubation when using this technique as well as complications (trauma to the oral cavity, dental trauma, and regurgitation seen by the anaesthesiologist) that may occur. Also saturation (SpO2) at the end of the procedure will be noted and adjuncts that are used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed patient consent Age \\> 18 years History of difficult intubation (Cormack and Lehane III-IV)\n\nOne or more predictors of a difficult intubation:\n\n* restricted neck movement\n* thyromental distance \\< 60 mm\n* interincisor/interdental distance \\< 30mm\n* BMI \\> 35 kg.m-2 Elective surgery making endotracheal intubation necessary (other than head and/or neck surgery) Fasted (≥ 6 hours)\n\nExclusion Criteria:\n\n* No informed patient consent Age \\< 18 years Emergency surgery, head and/or neck surgery Fasted \\< 6 hours'}, 'identificationModule': {'nctId': 'NCT01691703', 'briefTitle': 'Combined Technique for Difficult Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Catharina Ziekenhuis Eindhoven'}, 'officialTitle': 'Combined Technique Using Videolaryngoscopy and Bonfils for a Difficult Airway Intubation', 'orgStudyIdInfo': {'id': 'COM.12'}, 'secondaryIdInfos': [{'id': '12-624', 'type': 'OTHER', 'domain': 'Medisch Ethische Commissie Catharina Ziekenhuis Eindhoven'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Videolaryngoscope and Bonfils', 'description': 'First, the Macintosh videolaryngoscope (Karl Storz, Tuttlingen, Germany) will be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® (Karl Storz, Tuttlingen, Germany). Once the anaesthesiologist considers the view achieved to be the best view possible, a picture will be taken using C-CAMTM for C-MAC (Karl Storz, Tuttlingen, Germany), not showing any part of the videolaryngoscope. Thereafter the Bonfils® intubation scope, which will be preloaded with the endotracheal tube, will be brought into position in front of the laryngeal inlet. Again a picture not showing any part of one of the two devices will be taken. Once the Bonfils® has entered the trachea, the tracheal tube will be placed in the correct position.', 'interventionNames': ['Device: Videolaryngoscope and Bonfils']}], 'interventions': [{'name': 'Videolaryngoscope and Bonfils', 'type': 'DEVICE', 'otherNames': ['Macintosh videolaryngoscope (Karl Storz)', 'Bonfils® (Karl Storz)'], 'description': 'First, the Macintosh videolaryngoscope (Karl Storz, Tuttlingen, Germany) will be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® (Karl Storz, Tuttlingen, Germany). Once the anaesthesiologist considers the view achieved to be the best view possible, a picture will be taken using C-CAMTM for C-MAC (Karl Storz, Tuttlingen, Germany), not showing any part of the videolaryngoscope. Thereafter the Bonfils® intubation scope, which will be preloaded with the endotracheal tube, will be brought into position in front of the laryngeal inlet. Again a picture not showing any part of one of the two devices will be taken. Once the Bonfils® has entered the trachea, the tracheal tube will be placed in the correct position.', 'armGroupLabels': ['Videolaryngoscope and Bonfils']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5623 EJ', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis Eindhoven', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}], 'overallOfficials': [{'name': 'Barbe MA Pieters, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catharina Ziekenhuis Eindhoven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Barbe Pieters', 'investigatorAffiliation': 'Catharina Ziekenhuis Eindhoven'}}}}