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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (LMA Group) | Active Comparator | Active Comparator: Group A (LMA Group) LMA-Classicâ„¢ laryngeal mask airway (Classicâ„¢LMA) by Dr. Archie Brain into clinical practice in 1988 brought about a revolution in anesthesia. In the literature, there are over 2,500 studies supporting Classicâ„¢ LMA usage. Following the success and popularity of Classicâ„¢ LMA, many different variants of this device have been designed and marketed,trying to offer a simple and effective alternative to the endotracheal intubation. |
|
| Group B (I gel Group) | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laryngeal Mask Airway | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of insertion of each device . | Invistigators study Time of insertion of each device,Laryngeal Mask Airway and I gel | Half an hour |
| Measure | Description | Time Frame |
|---|---|---|
| Leaking pressure of each device. | Invistigators study Leaking pressure of each device,Laryngeal Mask Airway and I gel | Half an hour |
| Confirmation of position by fiber optic | Invistigators study Confirmation of position by fiber optic of each device,Laryngeal Mask Airway and I gel |
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Inclusion Criteria:
Exclusion Criteria:
5. any form of sore throat ,patients allergic to any drugs used in the study 6. PCV mode if measured tidal volume was lesser than 6 ml/kg it will be excluded.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahmed Abdalla Mohamed | Cairo | 11451 | Egypt |
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Investigators hypothesize that both supraglottic devices, the classic LMA and i gel are effective in ventilation of obese patient.
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50Patients are randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups:
|
| I gel Airway | Device | 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 |
|
| Half an hour |
| Blood Pressure | Investigators recorded a baseline reading of systolic blood pressure and diastolic blood pressure before insertion of both devices. A second reading was taken after insertion of both devices, just before removal. The fourth reading was recorded 1 min after removal of both devices. | 24 hours |
| Heart Rate | Investigators recorded a baseline reading of heart rate, before insertion of both devices. A second reading was taken after insertion of both devices, just before removal. The fourth reading was recorded 1 min after removal of both devices. | 24 hours |
| Oxygen saturation | Investigators recorded a baseline reading of Oxygen saturation before insertion of both devices. A second reading was taken after insertion of both devices, just before removal. The fourth reading was recorded 1 min after removal of both devices. | 24 hours |
| Postoperative complications | With regard to postoperative complications, after removal of the device, post operative blood stain in laryngeal mask and I gel | 24 hours |
| ID | Term |
|---|---|
| D017214 | Laryngeal Masks |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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