Does the Position of the Esophageal Entrance Determine the Cricoid Force Necessary to Occlude the Esophageal Lumen

Aspiration Clinical Trial

— CP  

Official title:

Does the Position of the Esophageal Entrance Determine the Cricoid Force Necessary to Occlude the Esophageal Lumen?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01746927
• Other study ID #: PRH05
• Status: Recruiting
• Phase: N/A
• First received: December 7, 2012
• Last updated: December 2, 2013
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: Procare Riaya Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This investigation was designed to assess if the the position of esophageal entrance would detrmine the cricoid force necessary to occlude the esophageal lumen? in anesthetized, paralyzed non obese patients using the Glidescope ® video laryngoscope (GVL).

Description:

80 adult patients (40 women, 40 men) scheduled to undergo elective surgical procedures requiring general anesthesia and necessitating endotracheal intubation, were included in this study. Patients eligible for participation were aged 18-60 yrs., ASA physical status I or II and BMI < 30 kg/m2. Before anesthesia induction, CP was verified as follow: the cricoid cartilage was first identified and then held between the thumb and middle finger and the pressure was applied by the index finger with a force that could be tolerated by the patient. After loss of consciousness, four predetermined forces: 0 , 10 , 20 and 30 N were chosen in a randomized method. Therefore, after applying the predetermined force, a GT 20 F insertion trial was performed and two outcomes were considered: 1) Failure of GT insertion: effective CP. The next trials were not attempted. 2) Success of GT insertion: ineffective CP. The patient received a second attempt with increasing force to the next scale of force. If the attempt was effective (failure of GT insertion) , the relevant force is considered as the effective CP force. Same trial was repeated using 0, 10, 20 and 30 N respectively in in a randomized fashion for each patient. The cricoid force was standardized by reproducing 10, 20 and 30 N on a weighing scale prior to each application.

Four anesthesia providers (operators) participated in the study: The first operator performed CP in all patients with his back towards the video monitor; the second operator performed laryngoscopy using GVL and GT insertion trials and he was not aware about the nature of study ; the third operator assessed the effectiveness of the applied CP and determined the position of the esophageal entrance in relation to the glottis. The fourth operator, who was standing behind the second operator, signaled to the second operator to start attempt for each trial with the predetermined CP forces and to the first operator who applying CP to stop or continue accordingly.

In order to "blind" the second operator, a screen separated the laryngoscopist and the first operator applying CP, while the hand position for the CP was maintained, even when CP was not applied. Data collected before staring surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

•No-obese patients (BMI < 30)

• ASA 1&2

• G.A needs intubation

Exclusion Criteria:

• ASA 3 and 4

• Contre indication to cricoid pressure

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aspiration

Intervention

Other:
• Glidescope Cricoid pressure
The current study test by direct visual evidence the occlusion of esophageal entrance during application CP. The closure of the lumen was further demonstrated by the inability to introduce a GT into the esophagus during CP. using in radimized method : 0 N,10 N, 20N AND 30 N

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	Efficacy of Cricoid Pressure for Prevention of Aspiration		24 hours	Yes