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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Procare Riaya Hospital
Sponsor:
Information provided by (Responsible Party):
Ahed ZEIDAN, Procare Riaya Hospital
ClinicalTrials.gov Identifier:
NCT01746927
First received: December 7, 2012
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention
Aspiration
Other: Glidescope Cricoid pressure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Does the Position of the Esophageal Entrance Determine the Cricoid Force Necessary to Occlude the Esophageal Lumen?

Further study details as provided by Procare Riaya Hospital:

Primary Outcome Measures:
  • Efficacy of Cricoid Pressure for Prevention of Aspiration [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
cricoid pressure 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
Other Name: Glidescope Cricoid pressure

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

normal healthy non obese patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746927

Locations
Saudi Arabia
Procare Riaya Hospital Recruiting
Al Khobar, Estern, Saudi Arabia, 31952
Contact: Kamal Abdulkhalek, M.D.    00966505814754 ext 1140    doczeidan@hotmail.com   
Principal Investigator: AHED ZEIDAN, MD         
Sponsors and Collaborators
Procare Riaya Hospital
Investigators
Study Chair: Ahed Zeidan, MD Procare Riaya Hospital
  More Information

No publications provided

Responsible Party: Ahed ZEIDAN, CONSULTANT ANESTHESIELOGIST, Procare Riaya Hospital
ClinicalTrials.gov Identifier: NCT01746927     History of Changes
Other Study ID Numbers: PRH05
Study First Received: December 7, 2012
Last Updated: December 2, 2013
Health Authority: Saudi Arabia: Ethics Committee

Keywords provided by Procare Riaya Hospital:
cricoid pressure, glidescope

ClinicalTrials.gov processed this record on November 20, 2014