Cricoid Pressure vs. Paralaryngeal Pressure to Prevent Regurgitation

Completed

• Conditions: Intubation Complication

• Registration Number: NCT03558633
• Lead Sponsor: SMG-SNU Boramae Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-04-26
• Study Start: 2018-06-01
• Study First Submitted QC: 2018-06-14
• Study First Posted: 2018-06-15
• Primary Completion: 2019-06-05
• Study Completion: 2019-06-05
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occlusion of esophagus	for 1 minute during direct laryngosopy	Occlusion of esophagus is checked under the application of cricoid and paralaryngeal pressures during direct laryngsocpy

Secondary Outcome Measures

Name	Time	Method
The relative position of the upper esophageal end to the glottis	1 minute before and after the induction of anesthesia, during direct laryngoscopy	The position assessed by using ultrasonography and direct visualization
The outer anteroposterior diameter of the upper esophageal end	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.
POGO score	during direct laryngoscopy	POGO score under the application of cricoid and paralaryngeal pressures

Trial Locations

Locations (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of