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

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 .

Study Overview

• Status: Unknown
• Conditions: ASPIRATION
• Intervention / Treatment: Device: Cricoid pressure

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Estern
    • Al Khobar, Estern, Saudi Arabia, 31952
      • Procare Riaya Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1 , cricoid pressure; 30 male	Device: Cricoid pressure; 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
Active Comparator: 2,cricoid pressure; 30 female	Device: Cricoid pressure; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Procare Riaya Hospital
• Investigators: Study Director: kamal abdulkhaleq, MD, Procare Riaya Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: November 27, 2015
• First Posted (Estimate): December 2, 2015

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 15, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PRH7