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

NCT05377346 | Completed

• 1 other identifier: 202205
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Paratracheal Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Tidal volume

  At 1 minute after the placement of the i-gel

• Peak inspiratory pressure

  At 1 minute after the placement of the i-gel

Study Arms (2)

Paratracheal pressure group

EXPERIMENTAL

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

Other: Placement of the i-gel

Cricoid pressure group

ACTIVE COMPARATOR

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

Other: Placement of the i-gel

Interventions

Placement of the i-gel 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; Paratracheal pressure group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective surgery under general anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• SMG-SNU Boramae Medical Center: lead

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

Location

Related Publications (1)

• 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.

  PMID: 38507025 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: September 1, 2022
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

KR (1)