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

Completed

• Conditions: Airway Management
• Interventions: Device: LMA

• Registration Number: NCT05920447
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-24
• Status Verified: 2023-05
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Study First Submitted: 2023-05-26
• Study First Submitted QC: 2023-06-17
• Last Update Submitted: 2023-06-17
• Study First Posted: 2023-06-27
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LMA	LMA	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.

Primary Outcome Measures

Name	Time	Method
Assess the safety of volume-controlled mode of ventilation.in the Lithotomy position during the procedure	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.

Secondary Outcome Measures

Name	Time	Method
THE incidence of complication among the two groups	through the procedure	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.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt