Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus
1 other identifier
interventional
40
1 country
1
Brief Summary
Comparing the effects of 'Cricoid pressure' or 'Paratracheal pressure' during direct laryngoscopy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2019
CompletedFirst Posted
Study publicly available on registry
June 20, 2019
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2022
CompletedFebruary 10, 2022
February 1, 2022
5 months
June 19, 2019
February 8, 2022
Conditions
Outcome Measures
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'.
During 1 minute under videolaryngoscopy
Secondary Outcomes (4)
Outer diameter of the esophagus
During 1 minute after injection of anesthetics during induction of anesthesia
Position of the oesophageal entrance relative to the glottis
During 1 minute after injection of anesthetics during induction of anesthesia and during videolaryngoscopy
Position of the upper oesophagus relative to the trachea
During 1 minute after injection of anesthetics during induction of anesthesia and during videolaryngoscopy
The best laryngeal view
Before and after the application of cricoid and paratracheal force during videolaryngoscopy
Study Arms (2)
Cricoid pressure
EXPERIMENTALCricoid pressure is applied in the anesthetized state and during video laryngoscopy
Paratracheal pressure
EXPERIMENTALParatracheal pressure is applied in the anesthetized state and during video laryngoscopy
Interventions
Cricoid pressure: pressure on the cricoid ring Paratracheal pressure: pressure on the left paratracheal region below the cricoid level
Eligibility Criteria
You may qualify if:
- Who would be scheduled any surgery under general anesthesia and agree with the purpose of the study
You may not qualify if:
- Risk of aspiration
- History of esophageal surgery
- Diseases or anatomical abnormalities of the neck, larynx, pharynx or esophagus
- Known or predicted difficult airway.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156-707, South Korea
Related Publications (1)
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.
PMID: 35913721DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
June 19, 2019
First Posted
June 20, 2019
Study Start
September 1, 2021
Primary Completion
January 25, 2022
Study Completion
January 25, 2022
Last Updated
February 10, 2022
Record last verified: 2022-02