Clinical Trials Logo
  1. Home
  2. Endotracheal Intubation
  3. NCT00624403

Comparison of Two Type of Laryngeal Mask : I-Gel & LMA ProSeal — I-Gel  

Endotracheal Intubation Clinical Trial

Official title:
LMA ProSeal & I-Gel : a Prospective Controlled Trial

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00624403
Study type Interventional
Source University Hospital, Bordeaux
Contact
Status Completed
Phase N/A
Start date March 2008
Completion date December 2013
View Details
See also
  Status Clinical Trial Phase
Completed NCT06089187 - Comparing Endotracheal Tube Cuff Pressure in Laparoscopic Abdominal Surgery: Saline vs. Air Inflation N/A
Completed NCT02395432 - A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Difficult Airway N/A
Completed NCT02395445 - A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Routine Airway Management N/A
Unknown status NCT01041066 - Nicardipine Versus Labetalol During Intubation N/A
Completed NCT03284892 - Screening and Intervention of Postextubation Dysphagia N/A
Recruiting NCT02395419 - A Comparison of Tracheal Intubation Using the Totaltrack vs the Airtraq Laryngoscope in Routine Airway Management N/A
Recruiting NCT02395406 - A Comparison of Tracheal Intubation Using the Totaltrack vs the Airtraq Laryngoscope in Difficult Airway Management N/A
Enrolling by invitation NCT02277015 - Intubation During Pediatric Resuscitation N/A
Completed NCT01169467 - Cerebral Perfusion Pressure Using Precedex and Other Sedatives Phase 3
Completed NCT00620386 - Endotracheal Intubation Using Bonfils Fibrescope Without Neuromuscular Blockade Phase 2/Phase 3
Completed NCT05069844 - Preoperative Gum Chewing for Different Durations to Prevent Sore Throat After Endotracheal Intubation N/A
Enrolling by invitation NCT05620108 - Intubating Conditions of Neuromuscular Blockade N/A
Completed NCT02741921 - Conventional Double-lumen Tube vs VivaSight DL N/A
Recruiting NCT02295657 - Double Lumen Tube Intubation N/A
Completed NCT01488370 - Comparison of 2 Laryngoscopes for Endotracheal Intubation in Children Younger Than 2 Years Old N/A
Recruiting NCT01006668 - Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care Phase 3
Recruiting NCT04483895 - Comparison Between the Oro-Helical Length Technique and the 7-8-9 Rule in Determination of the Ideal Endotracheal Tube Insertion Depth in Neonates N/A
Completed NCT04141267 - Inhaled Sedation Using the Anesthetic-conserving Device ( ANACONDA) in Prehospital Emergency Medecine.
Completed NCT01490580 - Premedication Trial for Tracheal Intubation of the NEOnate Phase 2/Phase 3
Completed NCT03878797 - The Depth of Endotracheal Tube Insertion