Effect of Paratracheal and Cricoid Pressure on the Placement of the I-gel.

SMG-SNU Boramae Medical Center76 enrolled

Overview

This study aims to compare the effect of paratracheal and cricoid pressure on placement of the i-gel in terms of the success rate of i-gel insertion, time to placement, the rate of optimal position of the device, and difficulty of i-gel placement.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Paratracheal Pressure

Interventions

Placement of the i-gelOTHER

The lubricated i-gel is inserted into the mouth and introduced along the hard palate with a continuous and gentle push until resistance was felt in the hypopharynx.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients scheduled for elective surgery under general anesthesia Exclusion Criteria: * Presence of an upper airway anatomic variation or pathology * Increased risk of pulmonary aspiration * Known or predicted difficult airway * Surgery requiring lateral or prone position, head and neck surgery * Requirements for postoperative ventilator care.

Locations (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

The success rate of the i-gel placement

Successful placement of the i-gel is determined by proper chest expansion, the presence of a square waveform on the capnogram, absence of an audible leak, and lack of gastric insufflations.

Time frame: Immediately after the placement of the i-gel

Secondary Outcomes

Time to placement of the i-gel

Time to placement is defined as the time from picking up the i-gel to observing the end-tidal CO2 waveform.

Time frame: Immediately after the placement of the i-gel

The rate of optimal position of the i-gel

The anatomic position of the device is evaluated using a fiberoptic bronchoscope and graded on a scale of 1-4 as follows: 4, only the vocal cords seen; 3, vocal cords and posterior part of the epiglottis seen; 2, vocal cords and anterior part of the epiglottis seen; 1, vocal cords not seen, but adequate ventilation

Time frame: Immediately after the placement of the i-gel

Difficulty of the i-gel placement

Difficulty of the i-gel placement is assessed as follows; 1, very easy; 2, easy; 3, moderate; 4, difficult; 5. very difficult

Time frame: Immediately after the placement of the i-gel

Tidal volume

Tidal volume is assessed with or without each pressure using the ventilator setting (volume-control mode with a tidal volume of 8 mL/kg of ideal body weight, respiratory rate of 12 breaths/min, and zero end-expiratory pressure).

Time frame: At 1 minute after the placement of the i-gel

Peak inspiratory pressure

Peak inspiratory pressure is assessed with or without each pressure using the ventilator setting (volume-control mode with a tidal volume of 8 mL/kg of ideal body weight, respiratory rate of 12 breaths/min, and zero end-expiratory pressure)..

Data from ClinicalTrials.gov

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