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

A

Ain Shams University

Status

Completed

Conditions

Airway Management

Treatments

Device: LMA

Study type

Observational

Funder types

Other

Identifiers

NCT05920447
FMASU R 76/2021

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

60 participants in 2 patient groups

ETT
Description:
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
Description:
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.
Treatment:
Device: LMA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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