Paratracheal Force Required for Occluding the Upper Esophagus

NCT04110899 | Completed

• 1 other identifier: 2019-6209
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia Intubation Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The 95% paratracheal force

  During 1 min after the completion of anesthesia induction

Study Arms (1)

Different paratracheal force

EXPERIMENTAL

Esophageal occlusion is assessed by inserting an esophageal stethoscope under different paratracheal forces.

Other: Application of paratracheal force

Interventions

Application of paratracheal force OTHER

An esophageal stethoscope is inserted into the upper esophagus under the application of different paratracheal force in anesthetized and paralyzed patients.

Different paratracheal force

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who are scheduled for elective surgery under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• SMG-SNU Boramae Medical Center: lead

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Masking Details: Participant: masked because the intervention is applied after anesthesia induction Care provider who inserts an esophageal stethoscope under a certain paratracheal force: masked. The amount of applied paratracheal force is not shown to this investigator
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Paratracheal force for occluding the upper esophagus is evaluated using the up-and-down sequential method.

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 1, 2019
• Study Start: March 3, 2020
• Primary Completion: June 10, 2020
• Study Completion: June 10, 2020
• Last Updated: June 19, 2020

Record last verified: 2020-06

Locations

KR (1)