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Completed

NCT Number: NCT03558633

Cricoid Pressure vs. Paralaryngeal Pressure to Prevent Regurgitation

Comparing the effects of ' Cricoid pressure' or 'Paralaryngeal pressure' during endotracheal intubation procedure.

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Key information

Conditions

Intubation Complication

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

About this study

Applying Cricoid pressure is widely used procedure to prevent gastric contents regurgitation during endotracheal intubation. To find out effectiveness external pressure is applied, the investigators will evaluate the relative position of esophagus and trachea. And also comparing the effects of Cricoid pressure and Paralaryngeal pressure during whole tracheal intubation procedures.

  • Confirm the relative positions between esophagus and trachea in awake patients by using ultrasonography.
  • Compare the effect of 'Cricoid pressure' and 'Paralaryngeal pressure' to esophageal opening during tracheal intubation procedure as below points.
  • Awake states. (Before sedation) 2) Anesthetized states. (After muscle relaxation) 3) During direct intubation procedure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Diseases or anatomical abnormalities in the neck, larynx, pharynx or esophagus,
  • Aspiration tendency
  • Known or predicted difficult airway.

Treatment and study plan

Primary outcomes

  1. Occlusion of esophagus

    Time frame: for 1 minute during direct laryngosopy

    Occlusion of esophagus is checked under the application of cricoid and paralaryngeal pressures during direct laryngsocpy

Secondary outcomes

  1. The relative position of the upper esophageal end to the glottis

    Time frame: 1 minute before and after the induction of anesthesia, during direct laryngoscopy

    The position assessed by using ultrasonography and direct visualization

  2. The outer anteroposterior diameter of the upper esophageal end

    Time frame: During 1 minute in awake and anesthetized paralyzed states

    The outer anteroposterior diameter of the upper esophageal end is assessed before and durng the application of cricoid and paralaryngeal pressures.

  3. POGO score

    Time frame: during direct laryngoscopy

    POGO score under the application of cricoid and paralaryngeal pressures

Sponsors and collaborators

Lead sponsor

SMG-SNU Boramae Medical Center

Other

Registry information

Official study title

A Comparison of the Effects of Cricoid Pressure and Paralaryngeal Pressure to Prevent Regurgitation of Gastric Contents

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 15, 2018
Registry last updated
Aug 16, 2019

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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