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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05377346
Enrollment
76
Registered
2022-05-17
Start date
2022-09-01
Completion date
2023-04-20
Last updated
2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paratracheal Pressure

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.

Interventions

OTHERPlacement 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.

Sponsors

SMG-SNU Boramae Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The success rate of the i-gel placementImmediately after the placement of the i-gelSuccessful 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

MeasureTime frameDescription
Time to placement of the i-gelImmediately after the placement of the i-gelTime 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-gelImmediately after the placement of the i-gelThe 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 placementImmediately after the placement of the i-gelDifficulty of the i-gel placement is assessed as follows; 1, very easy; 2, easy; 3, moderate; 4, difficult; 5. very difficult
Tidal volumeAt 1 minute after the placement of the i-gelTidal 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).
Peak inspiratory pressureAt 1 minute after the placement of the i-gelPeak 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)..

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026