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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-A01095-48 | Other Identifier | ANSM |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | LMA ProSeal |
|
| 2 | Experimental | I-Gel |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laryngeal mask insertion (LMA ProSeal) | Device | Laryngeal mask insertion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insertion success rate | At firste attempt of insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative morbidity | Perioperative period | |
| Airway sealing pressure | Once, when efficient ventilation is reached | |
| Accessibility for stomach tube insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Marie CROS, Dr | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniersity Hospital, Bordeaux | Bordeaux | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16859880 | Background | 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. | |
| 15361474 | Background | 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. |
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| Laryngeal mask insertion (I-Gel) | Device | Laryngeal mask insertion |
|
|
| Juste after laryngeal mask insertion |
| Fibre-optic grade | After insertion |
| 16103390 | Background | 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. |
| 11004067 | Background | 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. |
| 11878665 | Background | 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. |
| 16179048 | Background | 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. |
| 14570790 | Background | 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. |
| 12066729 | Background | 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. |