Safety and Limitation of the 2nd Generation Laryngeal Mask Airway in the Lithotomy Position: An Obsevational Study

Study Overview
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Brief Summary
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Laryngeal mask airway is used in different types of surgery requiring different position, recommendation was raised regarding the use of LMA in Lithotomy position with pressure controlled mode of ventilation. This raise a concern whether the mode of ventilation is a limitation for the use of LMA in these position, especially with the use of the i-gel LMA with the characteristic non-inflatable jelly cuff, that provides an excellent seal.

Official Title
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Safety and Limitation of the 2nd Generation Laryngeal Mask Airway in the Lithotomy Position: An Obsevational Study

Conditions
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Airway Management

Intervention / Treatment
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* Device: LMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged over 18 years Both gender Surgery mandating lithotomy position Exclusion Criteria: Patients' refusal Pregnant women Obesity (BMI > 39) Trendelenburg position Moderate to severe GERD Lengthy procedures (more than 120 min)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ETT<br>the patients in group T were intubated with Endotracheal tube (ETT) (flexicare) size 7 for female and 8 for male The patients were ventilated with a volume-controlled mode at a Tidal Volume (TV) 7ml/kg, Respiratory Rate 12 /min, I: E 1:2. The patient was then positioned in the lithotomy position. Ventilatory parameters including expired TV, peak airway pressure, inspired- expired TV and the end-tidal carbon dioxide were all monitored and recorded every 5 min. In case of leaking from the LMA that interfere with the ventilation before the patients were being positioned in the lithotomy position, the patients were excluded and replaced by another. The incidence of aspiration as revealed clinically( witnessed vomiting followed by decreased oxygen saturation, increased airway pressure, tachycardia, etc..) and confirmed radiologically, Failure of insertion or intubation, sore throat and air leak were reported as a complications. | |
| LMA<br>The patients in group L were intubated with an I gel Laryngeal mask airway (LMA) , the size was selected based on the body weight according to the manufacturer's instructions, The patients were then ventilated with a volume-controlled mode of ventilation at a Tidal Volume (TV) 7ml/kg, Respiratory Rate 12 /min, I: E 1:2. The patient was then positioned in the lithotomy position and secured Ventilatory parameters including expired TV, peak airway pressure, TV inspired- TV expired and the end-tidal CO2 were all monitored and recorded every 5 min. In case of leaking from the LMA that interfere with the ventilation before the patients were being positioned in the lithotomy position. The incidence of aspiration as revealed clinically( witnessed vomiting followed by decreased oxygen saturation, increased airway pressure, tachycardia, etc..) and confirmed radiologically, Failure of insertion or intubation, sore throat and air leak were reported as a complications. | Device: LMA<br>* Monitor the ventilatory parameter and incidence of complications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety of volume-controlled mode of ventilation.in the Lithotomy position during the procedure | Measuring the air Leak through measuring the difference between the inspired and expired tidal volume and determine the peak airway pressure at which these leak does occur. | During the Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| THE incidence of complication among the two groups | decreased oxygen saturation, increased airway pressure, tachycardia, etc..) and confirmed radiologically, Failure of insertion or intubation, sore throat and air leak were reported as a complications. | through the procedure |