The Cricoid Force Necessary to Occlude the Esophageal Entrance: Is There a Gender Difference?

Not Applicable

• Conditions: ASPIRATION
• Interventions: Device: Cricoid pressure

• Registration Number: NCT02618863
• Lead Sponsor: Procare Riaya Hospital

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 .

Detailed Description

60 (30 men; ages 18 - 50 yr; body mass index \< 28 kg/m2 physical status 1, 2 patients were recruited for the study. These patients were to undergo general anesthesia with tracheal intubation. starting force was 20 N in both sex. These forces were standardized by reproducing a new device : cricometer. The sequence of the applied forces was done by using the up and down method in both sex. After preoxygenation, anesthetic induction, muscular relaxation and mask ventilation, the study commenced. Direct laryngoscopy using the Glidescope video laryngoscope was performed and the view of the glottis and the esophageal entrance was video recorded with each CF. 2 attempts to insert a lubricated gastric tube (GT; size 20 F, 12 F) were carried out by a "blinded" operator in each patient. A successful insertion of the GT indicated a patent esophagus. When this occurred while CP was applied, it indicated ineffective CP. An unsuccessful insertion of the GT while CP was applied indicated a non-patent esophagus (effective CP). The position of the esophageal entrance relative to the glottis during CP was assessed from the video recordings.

Study Timeline

• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-27
• Study Start: 2015-12
• Study First Posted: 2015-12-02
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Last Update Submitted: 2016-02-15
• Last Update Posted: 2016-02-17
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA 1 - 2
• Easy Identification cricoid cartilage
• No contre indication to CP

Exclusion Criteria

• obese patients
• ASA2 & ASA3
• contre indication to CP

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2,cricoid pressure	Cricoid pressure	30 female
1 , cricoid pressure	Cricoid pressure	30 male

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Procare Riaya Hospital; 🇸🇦 Al Khobar, Estern, Saudi Arabia