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Paratracheal Force Required for Occluding the Upper Esophagus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110899
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
Jin-Young Hwang, SMG-SNU Boramae Medical Center

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.

Condition or disease Intervention/treatment Phase
Anesthesia Intubation Complication Other: Application of paratracheal force Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Paratracheal force for occluding the upper esophagus is evaluated using the up-and-down sequential method.
Masking: None (Open Label)
Masking Description: 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
Primary Purpose: Prevention
Official Title: Paratracheal Force Required for Occluding the Upper Esophagus in Anesthetized and Paralyzed Patients
Actual Study Start Date : March 3, 2020
Actual Primary Completion Date : June 10, 2020
Actual Study Completion Date : June 10, 2020

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.




Primary Outcome Measures :
  1. Median paratracheal force [ Time Frame: During 1 min after the completion of anesthesia induction ]
    Esophageal occlusion is evaluated under different paratracheal force by inserting the esophageal stethoscope


Secondary Outcome Measures :
  1. The 95% paratracheal force [ Time Frame: During 1 min after the completion of anesthesia induction ]
    Esophageal occlusion is evaluated under different paratracheal force by inserting the esophageal stethoscope



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110899


Locations
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Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
SMG-SNU Boramae Medical Center
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Responsible Party: Jin-Young Hwang, Associate professor, SMG-SNU Boramae Medical Center
ClinicalTrials.gov Identifier: NCT04110899    
Other Study ID Numbers: 2019-6209
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No