Cricoid Pressure vs. Paralaryngeal Pressure to Prevent Regurgitation

Intubation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558633
• Other study ID #: 20180222/30-2018-11/033
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: June 5, 2019

Study information

• Verified date: August 2019
• Source: SMG-SNU Boramae Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 5, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intubation Complication

Locations

Country	Name	City	State
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Koenig SJ, Lakticova V, Mayo PH. Utility of ultrasonography for detection of gastric fluid during urgent endotracheal intubation. Intensive Care Med. 2011 Apr;37(4):627-31. doi: 10.1007/s00134-010-2125-9. Epub 2011 Feb 2. — View Citation

Lienhart A, Auroy Y, Péquignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. — View Citation

Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occlusion of esophagus	Occlusion of esophagus is checked under the application of cricoid and paralaryngeal pressures during direct laryngsocpy	for 1 minute during direct laryngosopy
Secondary	The relative position of the upper esophageal end to the glottis	The position assessed by using ultrasonography and direct visualization	1 minute before and after the induction of anesthesia, during direct laryngoscopy
Secondary	The outer anteroposterior diameter of the upper esophageal end	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
Secondary	POGO score	POGO score under the application of cricoid and paralaryngeal pressures	during direct laryngoscopy