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OpenTrials
Completed

NCT Number: NCT05920447

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LMA

Device

Monitor the ventilatory parameter and incidence of complications

Primary outcomes

  1. Assess the safety of volume-controlled mode of ventilation.in the Lithotomy position during the procedure

    Time frame: 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 outcomes

  1. THE incidence of complication among the two groups

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Acronym: LMA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 27, 2023
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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