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

Study Overview
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Brief Summary
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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.

Official Title
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A Comparison of the Effect of Paratracheal and Cricoid Pressure on the Placement of the I-gel.

Conditions
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Paratracheal Pressure

Intervention / Treatment
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* Other: Placement of the i-gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paratracheal pressure group<br>After the induction of anesthesia, the i-gel is placed under the application of paratracheal pressure. | Other: Placement of the i-gel<br>* 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.<br>|
| Active Comparator: Cricoid pressure group<br>After the induction of anesthesia, the i-gel is placed under the application of cricoid pressure. | Other: Placement of the i-gel<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediately after the placement of the i-gel | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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). | 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).. | At 1 minute after the placement of the i-gel |