Cricoid Pressure vs. Paralaryngeal Pressure to Prevent Regurgitation

August 13, 2019 updated by: Jin-Young Hwang, SMG-SNU Boramae Medical Center

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

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

  1. Confirm the relative positions between esophagus and trachea in awake patients by using ultrasonography.
  2. Compare the effect of 'Cricoid pressure' and 'Paralaryngeal pressure' to esophageal opening during tracheal intubation procedure as below points.

1) Awake states. (Before sedation) 2) Anesthetized states. (After muscle relaxation) 3) During direct intubation procedure.

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Who has any surgery under general anesthesia and agree with the purpose of the study

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
for 1 minute during direct laryngosopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 minute before and after the induction of anesthesia, during direct laryngoscopy
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.
During 1 minute in awake and anesthetized paralyzed states
POGO score
Time Frame: during direct laryngoscopy
POGO score under the application of cricoid and paralaryngeal pressures
during direct laryngoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SMG-SNU Boramae Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

June 5, 2019

Study Completion (Actual)

June 5, 2019

Study Registration Dates

First Submitted

April 26, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (Actual)

June 15, 2018

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20180222/30-2018-11/033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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