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Clinical Trials/NCT05377346
NCT05377346CompletedNot Applicable

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

SMG-SNU Boramae Medical Center1 site in 1 country76 target enrollmentStarted: September 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
76
Locations
1
Primary Endpoint
The success rate of the i-gel placement

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

Paratracheal pressure group

Experimental

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

Intervention: Placement of the i-gel (Other)

Cricoid pressure group

Active Comparator

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

Intervention: Placement of the i-gel (Other)

Outcomes

Primary Outcomes

The success rate of the i-gel placement

Time Frame: 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 Outcomes

  • Time to placement of the i-gel(Immediately after the placement of the i-gel)
  • The rate of optimal position of the i-gel(Immediately after the placement of the i-gel)
  • Difficulty of the i-gel placement(Immediately after the placement of the i-gel)
  • Peak inspiratory pressure(At 1 minute after the placement of the i-gel)
  • Tidal volume(At 1 minute after the placement of the i-gel)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jin-Young Hwang

Professor

SMG-SNU Boramae Medical Center

Study Sites (1)

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