Determination of the Left Paratrachéal Force Required to Occlude the Esophageal Entrance

January 27, 2022 updated by: Benjamin Javillier, MD, University of Liege
Determine the force required to occlude the esophagus with a left paratracheal pressure

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Physical status score 1 or 2
  • No contre indication to Left Paratracheal pressure

Exclusion Criteria:

  • Obese patients
  • Physical status score 3, 4 or 5
  • Contre indication to Left Paratracheal pressure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 , Left paratracheal pressure
50 male
Device: Left paratracheal pressure
Applying Left Paratracheal pressure and testing its effectiveness using gastric tube . in addition , by using the dynamometer , the CP 50 is defined.
Active Comparator: 2, Left paratracheal pressure
50 female
Device: Left paratracheal pressure
Applying Left Paratracheal pressure and testing its effectiveness using gastric tube . in addition , by using the dynamometer , the CP 50 is defined.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Necessary force of Left paratracheal pressure to occlude the esophagus in female versus male . an up and down method will define the CP 50 in each gender. A comparison between CP50 in both sex will define exactly our outcome
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

July 30, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Strenght_LPP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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