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

Not Applicable

Completed

• Conditions: Paratracheal Pressure
• Interventions: Other: Placement of the i-gel

• Registration Number: NCT05377346
• Lead Sponsor: SMG-SNU Boramae Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-17
• Study Start: 2022-09-01
• Primary Completion: 2023-04-20
• Study Completion: 2023-04-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cricoid pressure group	Placement of the i-gel	After the induction of anesthesia, the i-gel is placed under the application of cricoid pressure.
Paratracheal pressure group	Placement of the i-gel	After the induction of anesthesia, the i-gel is placed under the application of paratracheal pressure.

Primary Outcome Measures

Name	Time	Method
The success rate of the i-gel placement	Immediately after the placement of the i-gel	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.

Secondary Outcome Measures

Name	Time	Method
Time to placement of the i-gel	Immediately after the 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.
The rate of optimal position of the i-gel	Immediately after the placement 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
Difficulty of the i-gel placement	Immediately after the placement of the i-gel	Difficulty of the i-gel placement is assessed as follows; 1, very easy; 2, easy; 3, moderate; 4, difficult; 5. very difficult
Peak inspiratory pressure	At 1 minute after the placement of the i-gel	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)..
Tidal volume	At 1 minute after the placement of the i-gel	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).

Trial Locations

Locations (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of