Comparison of Two Type of Laryngeal Mask : I-Gel & LMA ProSeal
NCT ID: NCT00624403
Last Updated: 2015-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
700 participants
INTERVENTIONAL
2008-03-31
2013-12-31
Brief Summary
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Detailed Description
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The 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
LMA ProSeal
Laryngeal mask insertion (LMA ProSeal)
Laryngeal mask insertion
2
I-Gel
Laryngeal mask insertion (I-Gel)
Laryngeal mask insertion
Interventions
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Laryngeal mask insertion (LMA ProSeal)
Laryngeal mask insertion
Laryngeal mask insertion (I-Gel)
Laryngeal mask insertion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Surgery allowing the use of laryngeal mask as airway management
* Written informed consent
Exclusion Criteria
* Pulmonary disease
* Gastroesophageal reflux antecedent
* Coeliosurgery
* Inhalation risk
* Hiatus hernia
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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University Hospital, Bordeaux
Principal Investigators
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Anne-Marie CROS, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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Uniersity Hospital, Bordeaux
Bordeaux, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CHUBX 2007/22
Identifier Type: -
Identifier Source: org_study_id
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