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

NCT ID: NCT05377346

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-04-20

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.

Detailed Description

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Conditions

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Paratracheal Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Paratracheal pressure group

After the induction of anesthesia, the i-gel is placed under the application of paratracheal pressure.

Group Type EXPERIMENTAL

Placement of the i-gel

Intervention Type OTHER

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.

Cricoid pressure group

After the induction of anesthesia, the i-gel is placed under the application of cricoid pressure.

Group Type ACTIVE_COMPARATOR

Placement of the i-gel

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SMG-SNU Boramae Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jin-Young Hwang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Won D, Kim H, Chang JE, Lee JM, Kim TK, Kim H, Min SW, Hwang JY. Comparison of the effects of paratracheal pressure and cricoid pressure on placement of the i-gel(R) supraglottic airway: a randomized clinical trial. Can J Anaesth. 2024 Jul;71(7):996-1003. doi: 10.1007/s12630-024-02741-1. Epub 2024 Mar 20.

Reference Type DERIVED
PMID: 38507025 (View on PubMed)

Other Identifiers

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202205

Identifier Type: -

Identifier Source: org_study_id

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