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

Procare Riaya Hospital

Status: Unknown

Conditions: ASPIRATION

Treatments: Device: Cricoid pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT02618863

PRH7

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

1 , cricoid pressure

Active Comparator group

Description:

30 male

Treatment:

Device: Cricoid pressure

2,cricoid pressure

Active Comparator group

Description:

30 female

Treatment:

Device: Cricoid pressure