Back to resultsDetermination of the Left Paratrachéal Force Required to Occlude the Esophageal Entrance
Primary Purpose
Oesophageal Reflux
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Left paratracheal pressure
Sponsored by
About this trial
This is an interventional prevention trial for Oesophageal Reflux
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1 , Left paratracheal pressure
2, Left paratracheal pressure
Arm Description
50 male
50 female
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05214079
Brief Title
Determination of the Left Paratrachéal Force Required to Occlude the Esophageal Entrance
Official Title
Determination of the Left Paratrachéal Force Required to Occlude the Esophageal Entrance
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
July 30, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Determine the force required to occlude the esophagus with a left paratracheal pressure
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oesophageal Reflux
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 , Left paratracheal pressure
Arm Type
Active Comparator
Arm Description
50 male
Arm Title
2, Left paratracheal pressure
Arm Type
Active Comparator
Arm Description
50 female
Intervention Type
Device
Intervention Name(s)
Left paratracheal pressure
Intervention Description
Applying Left Paratracheal pressure and testing its effectiveness using gastric tube . in addition , by using the dynamometer , the CP 50 is defined.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Javillier, MD
Phone
43667180
Ext
+32
Email
javillier.benjamin@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Determination of the Left Paratrachéal Force Required to Occlude the Esophageal Entrance
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