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

Paratracheal Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05377346
• Other study ID #: 202205
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: April 20, 2023

Study information

• Verified date: July 2023
• Source: SMG-SNU Boramae Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Paratracheal Pressure

Intervention

Other:
• Placement of the i-gel
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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