- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01746927
Does the Position of the Esophageal Entrance Determine the Cricoid Force Necessary to Occlude the Esophageal Lumen (CP)
Does the Position of the Esophageal Entrance Determine the Cricoid Force Necessary to Occlude the Esophageal Lumen?
Study Overview
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Estern
-
Al Khobar, Estern, Saudi Arabia, 31952
- Recruiting
- Procare Riaya Hospital
-
Contact:
- Kamal Abdulkhalek, M.D.
- Phone Number: 1140 00966505814754
- Email: doczeidan@hotmail.com
-
Principal Investigator:
- AHED ZEIDAN, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy of Cricoid Pressure for Prevention of Aspiration
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PRH05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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