CClinicalTrials.gg
CompletedNCT03992950Updated Feb 10, 2022

Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus

An interventional study of Maneuvers for occluding esophagus in Intubation Complication, sponsored by SMG-SNU Boramae Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-02-10.

Sponsored by SMG-SNU Boramae Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

Comparing the effects of 'Cricoid pressure' or 'Paratracheal pressure' during direct laryngoscopy

Read the detailed description

The effectiveness of cricoid pressure and paratracheal pressure for occluding esophagus during direct and video laryngoscopies.

02

Conditions studied

  • Intubation Complication
03

In context

Lead sponsor

SMG-SNU Boramae Medical Center is the lead sponsor of 38 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Who would be scheduled any surgery under general anesthesia and agree with the purpose of the study

Exclusion criteria

Exclusion Criteria:

  • Risk of aspiration
  • History of esophageal surgery
  • Diseases or anatomical abnormalities of the neck, larynx, pharynx or esophagus
  • Known or predicted difficult airway.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Cricoid pressure

    Cricoid pressure is applied in the anesthetized state and during video laryngoscopy

    Other: Maneuvers for occluding esophagus

  • Experimental
    Paratracheal pressure

    Paratracheal pressure is applied in the anesthetized state and during video laryngoscopy

    Other: Maneuvers for occluding esophagus

Interventions

  • OtherManeuvers for occluding esophagus

    Cricoid pressure: pressure on the cricoid ring Paratracheal pressure: pressure on the left paratracheal region below the cricoid level

06

What researchers measure

Primary outcomes

  1. Occlusion of the esophagus

    Occlusion of the esophagus is checked with the application of cricoid and paratracheal pressures using esophageal stethoscope. If the esophageal stethoscope is not advanced into the esophagus, it is considered 'occlusion'.

    Time frame: During 1 minute under videolaryngoscopy

Secondary outcomes

  1. Outer diameter of the esophagus

    Outer diameter of the esophagus is measured using ultrasound before and after the application of cricoid and paratracheal pressures.

    Time frame: During 1 minute after injection of anesthetics during induction of anesthesia

  2. Position of the oesophageal entrance relative to the glottis

    Position of the oesophageal entrance relative to the glottis is evaluated.

    Time frame: During 1 minute after injection of anesthetics during induction of anesthesia and during videolaryngoscopy

  3. Position of the upper oesophagus relative to the trachea

    Position of the upper oesophagus relative to the trachea trachea is evaluated.

    Time frame: During 1 minute after injection of anesthetics during induction of anesthesia and during videolaryngoscopy

  4. The best laryngeal view

    The best laryngeal view is evaluated using the percentage of glottis opening (POGO) score, ranging from 0% to 100%.

    Time frame: Before and after the application of cricoid and paratracheal force during videolaryngoscopy

07

Study locations

1 site
  • Seoul Metropolitan Government Seoul National University Boramae Medical Center
    Seoul, 156-707, Korea, Republic of
08

References and documents

Publications

  • Kim H, Chang JE, Won D, Lee JM, Kim TK, Kim MJ, Min SW, Hwang JY. Effectiveness of Cricoid and Paratracheal Pressures in Occluding the Upper Esophagus Through Induction of Anesthesia and Videolaryngoscopy: A Randomized, Crossover Study. Anesth Analg. 2022 Nov 1;135(5):1064-1072. doi: 10.1213/ANE.0000000000006154. Epub 2022 Aug 1. PubMed 35913721 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03992950
Lead sponsor
SMG-SNU Boramae Medical Center
Responsible party
Jin-Young Hwang (Associate professor, SMG-SNU Boramae Medical Center) — Principal investigator
First posted
Jun 20, 2019
Start date
Sep 1, 2021
Primary completion
Jan 25, 2022
Completion
Jan 25, 2022
Last update
Feb 10, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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