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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05920447
Acronym
LMA
Enrollment
60
Registered
2023-06-27
Start date
2021-01-24
Completion date
2023-05-01
Last updated
2023-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management

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.

Interventions

DEVICELMA

Monitor the ventilatory parameter and incidence of complications

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Assess the safety of volume-controlled mode of ventilation.in the Lithotomy position during the procedureDuring the ProcedureMeasuring 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

MeasureTime frameDescription
THE incidence of complication among the two groupsthrough the proceduredecreased 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026