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

ASPIRATION Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02618863
• Other study ID #: PRH7
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 23, 2015
• Last updated: February 15, 2016
• Start date: December 2015
• Est. completion date: March 2016

Study information

• Verified date: February 2016
• Source: Procare Riaya Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of Health
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• ASPIRATION

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	Procare Riaya Hospital	Al Khobar	Estern

Sponsors (1)

Lead Sponsor	Collaborator
Procare Riaya Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes