Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus

Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus in Anesthetized and Paralyzed Patients During the Induction of Anesthesia

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

Study Overview

• Status: Completed
• Conditions: Intubation Complication
• Intervention / Treatment: Other: Maneuvers for occluding esophagus

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cricoid pressure; Cricoid pressure is applied in the anesthetized state and during video laryngoscopy	Other: Maneuvers for occluding esophagus; Cricoid pressure: pressure on the cricoid ring Paratracheal pressure: pressure on the left paratracheal region below the cricoid level
Experimental: Paratracheal pressure; Paratracheal pressure is applied in the anesthetized state and during video laryngoscopy	Other: Maneuvers for occluding esophagus; Cricoid pressure: pressure on the cricoid ring Paratracheal pressure: pressure on the left paratracheal region below the cricoid level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	During 1 minute under videolaryngoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outer diameter of the esophagus	Outer diameter of the esophagus is measured using ultrasound before and after the application of cricoid and paratracheal pressures.	During 1 minute after injection of anesthetics during induction of anesthesia
Position of the oesophageal entrance relative to the glottis	Position of the oesophageal entrance relative to the glottis is evaluated.	During 1 minute after injection of anesthetics during induction of anesthesia and during videolaryngoscopy
Position of the upper oesophagus relative to the trachea	Position of the upper oesophagus relative to the trachea trachea is evaluated.	During 1 minute after injection of anesthetics during induction of anesthesia and during videolaryngoscopy
The best laryngeal view	The best laryngeal view is evaluated using the percentage of glottis opening (POGO) score, ranging from 0% to 100%.	Before and after the application of cricoid and paratracheal force during videolaryngoscopy

Collaborators and Investigators

• Sponsor: SMG-SNU Boramae Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): January 25, 2022
• Study Completion (Actual): January 25, 2022

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 20, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: P2019-195

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No