The Cricoid Force Necessary to Occlude the Esophageal Entrance: Is There a Gender Difference?
1 other identifier
interventional
60
1 country
1
Brief Summary
the investigators have observed that women may require less CF than men to occlude the esophageal entrance, and that the routine use of 30 N in women may actually increase the incidence of airway-related problems. The objective of the current investigation was to test this hypothesis. In this study, real-time visual and dynamic means were used to assess the effectiveness of different forces applied to the cricoid cartilage in occluding the esophageal entrance in men and women. The patency of the esophageal entrance was directly visualized using the Glidescope Video Laryngoscope in anesthetized and paralyzed patients with and without CP. Evidence of closure of the esophageal lumen was confirmed by the inability to introduce a gastric tube (GT) into the esophagus under direct vision. New method , using Cricometer , was used to measure the applied force .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFebruary 17, 2016
February 1, 2016
2 months
November 23, 2015
February 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Necessary force of CP 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 : Is there a gender difference .
24 hours
Study Arms (2)
1 , cricoid pressure
ACTIVE COMPARATOR30 male
2,cricoid pressure
ACTIVE COMPARATOR30 female
Interventions
Applying cricoid pressure and testing its effectiveness using gastric tube . in addition , by using the cricometer , the CP 50 is defined and compared in both gender
Eligibility Criteria
You may qualify if:
- ASA 1 - 2
- Easy Identification cricoid cartilage
- No contre indication to CP
You may not qualify if:
- obese patients
- ASA2 \& ASA3
- contre indication to CP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Procare Riaya Hospital
Khobar, Estern, 31952, Saudi Arabia
Related Publications (1)
Zeidan AM, Salem MR, Bamadhaj M, Mazoit JX, Sadek H, Houjairy H, Abdulkhaleq K, Bamadhaj N. The Cricoid Force Necessary to Occlude the Esophageal Entrance: Is There a Gender Difference? Anesth Analg. 2017 Apr;124(4):1168-1173. doi: 10.1213/ANE.0000000000001631.
PMID: 28079588DERIVED
Study Officials
- STUDY DIRECTOR
kamal abdulkhaleq, MD
Procare Riaya Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.AHED ZEIDAN
Study Record Dates
First Submitted
November 23, 2015
First Posted
December 2, 2015
Study Start
December 1, 2015
Primary Completion
February 1, 2016
Study Completion
March 1, 2016
Last Updated
February 17, 2016
Record last verified: 2016-02