Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-05 @ 10:34 PM
Study NCT ID:
NCT00624403
Status:
COMPLETED
Last Update Posted:
2015-03-10
First Post:
2008-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Type of Laryngeal Mask : I-Gel & LMA ProSeal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-09', 'studyFirstSubmitDate': '2008-02-15', 'studyFirstSubmitQcDate': '2008-02-26', 'lastUpdatePostDateStruct': {'date': '2015-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insertion success rate', 'timeFrame': 'At firste attempt of insertion'}], 'secondaryOutcomes': [{'measure': 'Perioperative morbidity', 'timeFrame': 'Perioperative period'}, {'measure': 'Airway sealing pressure', 'timeFrame': 'Once, when efficient ventilation is reached'}, {'measure': 'Accessibility for stomach tube insertion', 'timeFrame': 'Juste after laryngeal mask insertion'}, {'measure': 'Fibre-optic grade', 'timeFrame': 'After insertion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Laryngeal mask airway'], 'conditions': ['Endotracheal Intubation']}, 'referencesModule': {'references': [{'pmid': '16859880', 'type': 'BACKGROUND', 'citation': 'Cros AM. [New laryngeal mask airway: easy and evolution to an better safety]. Ann Fr Anesth Reanim. 2006 Aug;25(8):804-5. doi: 10.1016/j.annfar.2006.06.009. Epub 2006 Jul 20. No abstract available. French.'}, {'pmid': '15361474', 'type': 'BACKGROUND', 'citation': 'Asai T. Editorial II: Who is at increased risk of pulmonary aspiration? Br J Anaesth. 2004 Oct;93(4):497-500. doi: 10.1093/bja/aeh234. No abstract available.'}, {'pmid': '16103390', 'type': 'BACKGROUND', 'citation': 'Cook TM, Lee G, Nolan JP. The ProSeal laryngeal mask airway: a review of the literature. Can J Anaesth. 2005 Aug-Sep;52(7):739-60. doi: 10.1007/BF03016565.'}, {'pmid': '11004067', 'type': 'BACKGROUND', 'citation': 'Keller C, Brimacombe J, Kleinsasser A, Loeckinger A. Does the ProSeal laryngeal mask airway prevent aspiration of regurgitated fluid? Anesth Analg. 2000 Oct;91(4):1017-20. doi: 10.1097/00000539-200010000-00046.'}, {'pmid': '11878665', 'type': 'BACKGROUND', 'citation': 'Brimacombe J, Richardson C, Keller C, Donald S. Mechanical closure of the vocal cords with the laryngeal mask airway ProSeal. Br J Anaesth. 2002 Feb;88(2):296-7. doi: 10.1093/bja/88.2.296.'}, {'pmid': '16179048', 'type': 'BACKGROUND', 'citation': 'Levitan RM, Kinkle WC. Initial anatomic investigations of the I-gel airway: a novel supraglottic airway without inflatable cuff. Anaesthesia. 2005 Oct;60(10):1022-6. doi: 10.1111/j.1365-2044.2005.04258.x.'}, {'pmid': '14570790', 'type': 'BACKGROUND', 'citation': 'Cook TM, McKinstry C, Hardy R, Twigg S. Randomized crossover comparison of the ProSeal laryngeal mask airway with the Laryngeal Tube during anaesthesia with controlled ventilation. Br J Anaesth. 2003 Nov;91(5):678-83. doi: 10.1093/bja/aeg239.'}, {'pmid': '12066729', 'type': 'BACKGROUND', 'citation': 'Cook TM, Nolan JP, Verghese C, Strube PJ, Lees M, Millar JM, Baskett PJ. Randomized crossover comparison of the proseal with the classic laryngeal mask airway in unparalysed anaesthetized patients. Br J Anaesth. 2002 Apr;88(4):527-33. doi: 10.1093/bja/88.4.527.'}]}, 'descriptionModule': {'briefSummary': 'The i-gel is a new supra glottic airway device with a non inflatable cuff and an oesophageal vent. The aim of this study is to compare this device to the LMA ProSeal. The study is approved by the institutional ethic committee. 222 patients will be enrolled in each group. The objectives of the study will be to compare insertion success rate, leak pressure, ventilatory parameters and adverse event rate.', 'detailedDescription': "Supraglottic airway devices are now widely used for surgery requiring general anesthesia. Airway devices are safe and their morbidity rate is very low. The i-gel (Intersurgical Ltd, Wokingham, Berkshire, UK) is a new single-use non-inflatable supraglottic airway device that has not been evaluated in a comparative study.\n\nThe aim of this study is to compare i-gel with the LMA ProSeal in a randomized study. Anesthesia protocol is standardized. The supraglottic devices are compared in term of insertion success rate, leak pressure, ventilatory parameters and adverse events. The aim is to demonstrate an enhancement in term of insertion success rate and a diminution of the adverse events. Statistical analysis will used percentage, confidence interval and chi 2 or Fischer's exact test for qualitative data. Quantitative data will be analyzed in mean, standard deviation. Comparison will be made with a student t test or a wilcoxon test. P \\< 0,05 is statistically significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight \\> 30 kg\n* Surgery allowing the use of laryngeal mask as airway management\n* Written informed consent\n\nExclusion Criteria:\n\n* Difficult intubation criteria (defined by French Anesthesia-Reanimation Society)\n* Pulmonary disease\n* Gastroesophageal reflux antecedent\n* Coeliosurgery\n* Inhalation risk\n* Hiatus hernia'}, 'identificationModule': {'nctId': 'NCT00624403', 'acronym': 'I-Gel', 'briefTitle': 'Comparison of Two Type of Laryngeal Mask : I-Gel & LMA ProSeal', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'LMA ProSeal & I-Gel : a Prospective Controlled Trial', 'orgStudyIdInfo': {'id': 'CHUBX 2007/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'LMA ProSeal', 'interventionNames': ['Device: Laryngeal mask insertion (LMA ProSeal)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'I-Gel', 'interventionNames': ['Device: Laryngeal mask insertion (I-Gel)']}], 'interventions': [{'name': 'Laryngeal mask insertion (LMA ProSeal)', 'type': 'DEVICE', 'otherNames': ['LMA ProSeal'], 'description': 'Laryngeal mask insertion', 'armGroupLabels': ['1']}, {'name': 'Laryngeal mask insertion (I-Gel)', 'type': 'DEVICE', 'otherNames': ['I-Gel'], 'description': 'Laryngeal mask insertion', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Uniersity Hospital, Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Anne-Marie CROS, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jean-Pierre LEROY - Clinical Research and Innovation Director (General Director delegation)', 'oldOrganization': 'University Hospital, Bordeaux'}}}}