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

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.

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Device: LMA

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • ain shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The patients in group L were intubated with an Igel LMA (Intersurgical) , the size was selected based on the body weight according to the manufacturer's instructions, the patients in group T were intubated with ETT (flexicare) size 7 for female and 8 for male

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.

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ETT; 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; 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; Monitor the ventilatory parameter and incidence of complications

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2021
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: June 17, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FMASU R 76/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No