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Completed

NCT Number: NCT05377346

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

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.

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Key information

Conditions

Paratracheal Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Time to placement of the i-gel

    Time frame: Immediately after the 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.

  2. The rate of optimal position of the i-gel

    Time frame: Immediately after the placement 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

  3. Difficulty of the i-gel placement

    Time frame: Immediately after the placement of the i-gel

    Difficulty of the i-gel placement is assessed as follows; 1, very easy; 2, easy; 3, moderate; 4, difficult; 5. very difficult

  4. Tidal volume

    Time frame: At 1 minute after the placement of the i-gel

    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).

  5. Peak inspiratory pressure

    Time frame: At 1 minute after the placement of the i-gel

    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)..

Sponsors and collaborators

Lead sponsor

SMG-SNU Boramae Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 17, 2022
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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