Endotracheal Intubation
Conditions
Keywords
Anesthesia, Laryngeal mask airway
Brief summary
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.
Detailed description
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.
Interventions
DEVICELaryngeal mask insertion (LMA ProSeal)
Laryngeal mask insertion
DEVICELaryngeal mask insertion (I-Gel)
Laryngeal mask insertion
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Weight \> 30 kg * Surgery allowing the use of laryngeal mask as airway management * Written informed consent
Exclusion criteria
* Difficult intubation criteria (defined by French Anesthesia-Reanimation Society) * Pulmonary disease * Gastroesophageal reflux antecedent * Coeliosurgery * Inhalation risk * Hiatus hernia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insertion success rate | At firste attempt of insertion |
Secondary
| Measure | Time frame |
|---|---|
| Perioperative morbidity | Perioperative period |
| Airway sealing pressure | Once, when efficient ventilation is reached |
| Accessibility for stomach tube insertion | Juste after laryngeal mask insertion |
| Fibre-optic grade | After insertion |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAnne-Marie CROS, Dr
University Hospital, Bordeaux
Outcome results
None listed