Clinical trial NCT03558633: Cricoid Pressure vs. Paralaryngeal Pressure to Prevent Regurgitation
Official title: A Comparison of the Effects of Cricoid Pressure and Paralaryngeal Pressure to Prevent Regurgitation of Gastric Contents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation Complication
Keywords: Cricoid pressure
Paralaryngeal pressure
Intubation
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Who has any surgery under general anesthesia and agree with the purpose of the study

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Occlusion of esophagus
timeFrame: for 1 minute during direct laryngosopy
Secondary outcomes:
measure: The relative position of the upper esophageal end to the glottis
timeFrame: 1 minute before and after the induction of anesthesia, during direct laryngoscopy
measure: The outer anteroposterior diameter of the upper esophageal end
timeFrame: During 1 minute in awake and anesthetized paralyzed states
measure: POGO score
timeFrame: during direct laryngoscopy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
References:
citation: Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.
citation: Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.
citation: 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.