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NCT05920447 Clinical Trial

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

Airway Management Clinical Trial

— LMA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05920447
Other study ID # FMASU R 76/2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 24, 2021
Est. completion date May 1, 2023

Study information
Verified date May 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date May 1, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• LMA
Monitor the ventilatory parameter and incidence of complications

Locations
Country Name City State
Egypt Ain Shams University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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