Effectiveness of Cricoid Pressure During Videolaryngoscopy Versus Direct Laryngoscopy

May 28, 2024 updated by: Seoul National University Hospital

Comparison of the Effectiveness of Cricoid Pressure on Upper Esophageal Obstruction During Videolaryngoscopy Versus Direct Laryngoscopy: a Randomized, Crossover Study

Compare the success rate of upper esophageal obstruction with cricoid pressure during videolaryngoscopy and direct laryngoscopy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Even with appropriate cricoid pressure, the lifting force of the laryngoscope during direct laryngoscopy for tracheal intubation may counteract the cricoid pressure, making esophageal obstruction ineffective. Compared to direct laryngoscopy, videolaryngoscopy requires less lifting force, and thus, the success rate of esophageal obstruction may be higher. This study aims to compare the success rate of upper esophageal obstruction with cricoid pressure during videolaryngoscopy and direct laryngoscopy.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients scheduled to have general anesthesia with tracheal intubation

Exclusion Criteria:

  • Gastroesophageal reflux disease, achalasia, bowel obstruction,
  • BMI > 35 kg/m2
  • Uncontrolled diabetes
  • Pregnancy
  • Previous esophageal, and gastric surgery
  • Dental damage or anticipated difficult airways
  • Who do not consent to the study

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: D-V group
the group that performs direct laryngoscopy first and then videolaryngoscopy
Other: Intubation device order

D-V group: the group that performs direct laryngoscopy first and then videolaryngoscopy.

V-D group: the group that performs video laryngoscopy first and then directlaryngoscopy."
Experimental: V-D group
the group that performs videolaryngoscopy first and then directlaryngoscopy
Other: Intubation device order

D-V group: the group that performs direct laryngoscopy first and then videolaryngoscopy.

V-D group: the group that performs video laryngoscopy first and then directlaryngoscopy."

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of esophageal obstruction during cricoid pressure
Time Frame: During general anesthesia induction
Success rate of esophageal obstruction during cricoid pressure
During general anesthesia induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esophageal diameter
Time Frame: During cricoid pressure
Esophageal diameter measured by ultrasound
During cricoid pressure
percentage of glottic opening score
Time Frame: During cricoid pressure
percentage of glottic opening
During cricoid pressure
Cormack-Lehane grade
Time Frame: During cricoid pressure
views obtained by laryngoscopy
During cricoid pressure

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: TAE KYONG KIM, SMG-SNU Boramae Medical Center

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 (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Estimated)

June 4, 2024

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CP during videolaryngoscopy

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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