Randomized Comparative Study Between Classic Laryngeal Mask Airway and I Gel Airway in Obese Patients Having BMI 35-40 During Elective Non Abdominal Surgery.
Condition: LMA Vs I Gel
Study type: Interventional

Summary: 
      Invistigators study both supraglottic airway devices; the classic LMA and the I GEL mask are
      satisfactory devices providing high airway leaking pressures. Although both devices provide
      high airway leaking pressures, Invistigators study revealed that the I gel mask provides a
      better seal with the glottic aperture and shorter time of insertion than cLMA. Both devices
      showed also effective ventilation, more hemodynamic stability and no episode of hypoxia with
      minimal post-operative complications.
    

Detailed description: 
      Because of the advantages of supraglottic devices over the conventional endotracheal
      intubation, they are now widely used in ventilation. The classic LMA is a first generation
      simple airway tube consists of two parts, the tube and the cuffed peri-laryngeal sealer mask
      which is designed to provide an oval seal around the laryngeal inlet. It is made of medical
      grade silicone; it can be autoclaved and reused many times. I gel is a new type of laryngeal
      mask and doesn't have an inflatable cuff. Because of its thermoplastic elastomer structure,
      it exactly adapts to the supraglottic tissue by binding with body temperature, thus
      minimising air leakage. The aim of this study is to compare between cLMA and I gel regarding
      insertion success rate, the time of insertion, leaking pressure, assessment of position by
      fiber optic, hemodynamic, Spo2 for each device during insertion and maintenance of general
      anaesthesia and postoperative complications in obese patients. This study was conducted in
      Kasr Al-Ainy Teaching Hospital, after obtaining approval from Kasr Al-Ainy hospital research
      ethical committee, written informed consents were taken from 50 patients, all of whom
      completed this study. Patients were randomly allocated into 2 equal groups, 25 each,
      according to the inclusion and exclusion criteria.

        -  GA (n=25) in which classic laryngeal mask was used for ventilation.

        -  GB (n=25) in which I gel was used for ventilation. In our study the median insertion
           time was in I gel lesser than cLMA (9 s vs 10 s) respectively that was statistically
           significant but clinically insignificance. Higher leaking pressure was in I gel group
           (25cmh2o vs 18cmh2o) than cLMA group that was statistically significant. Our main
           finding in the study was that both supraglottic airway devices; the classic LMA and the
           I GEL mask are satisfactory devices providing high airway leaking pressures. Although
           both devices provide high airway leaking pressures, our study revealed that the I gel
           mask provides a better seal with the glottic aperture and shorter time of insertion than
           cLMA. Both devices showed also effective ventilation, more hemodynamic stability and no
           episode of hypoxia with minimal postoperative complications.
    

Intervention name(s): Laryngeal Mask Airway; I gel Airway
Intervention type(s): Device; Device
Intervention description(s): The aim of this study is to compare between cLMA and I gel regarding insertion success rate, the time of insertion, leaking pressure, assessment of position by fiber optic, hemodynamic, Spo2 for each device during insertion and maintenance of general anaesthesia and postoperative complications in obese patients; I gel is a new type of laryngeal mask and doesn't have an inflatable cuff. Because of its thermoplastic elastomer structure, it exactly adapts to the supraglottic tissue by binding with body temperature, thus minimising air leakage
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Investigators hypothesize that both supraglottic devices, the classic LMA and i gel are effective in ventilation of obese patient.
Masking: Double (Participant, Care Provider)
Primary purpose: Diagnostic