Paratracheal Force Required for Occluding the Upper Esophagus

Paratracheal Force Required for Occluding the Upper Esophagus in Anesthetized and Paralyzed Patients

In this study, the median paratracheal force for occluding the upper esophagus are evaluated in anesthetized and paralyzed patients using the up-and-down technique.

Study Overview

• Status: Completed
• Conditions: Anesthesia Intubation Complication
• Intervention / Treatment: Other: Application of paratracheal force

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • SMG-SNU Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients who are scheduled for elective surgery under general anesthesia

Exclusion Criteria:

• diseases or anatomical abnormalities in the neck, larynx, pharynx or esophagus
• aspiration tendency
• history of carotid artery diseases or cerebrovascular diseases
• suspicious of thrombus in carotid artery on ultrasonographic examination

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Different paratracheal force; Esophageal occlusion is assessed by inserting an esophageal stethoscope under different paratracheal forces.	Other: Application of paratracheal force; An esophageal stethoscope is inserted into the upper esophagus under the application of different paratracheal force in anesthetized and paralyzed patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median paratracheal force	Esophageal occlusion is evaluated under different paratracheal force by inserting the esophageal stethoscope	During 1 min after the completion of anesthesia induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 95% paratracheal force	Esophageal occlusion is evaluated under different paratracheal force by inserting the esophageal stethoscope	During 1 min after the completion of anesthesia induction

Collaborators and Investigators

• Sponsor: SMG-SNU Boramae Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 3, 2020
• Primary Completion (ACTUAL): June 10, 2020
• Study Completion (ACTUAL): June 10, 2020

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (ACTUAL): October 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2019-6209

Drug and device information, study documents

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