Efficacy of Cricoid Pressure in Occluding the Esophageal Entrance: A Glidescope ® Study (CP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ahed ZEIDAN, Procare Riaya Hospital
ClinicalTrials.gov Identifier:
NCT01415661
First received: August 4, 2011
Last updated: April 7, 2012
Last verified: April 2012
  Purpose

This investigation was designed to assess the patency of the esophageal entrance during cricoid pressure (CP) in anesthetized, paralyzed obese and non obese patients using the Glidescope ® video laryngoscope (GVL).


Condition Intervention
Aspiration
Other: cricoid pressure

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of Cricoid Pressure in Occluding the Esophageal Entrance: A Glidescope ® Study

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 ]

Enrollment: 89
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: obese patient Other: 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.
Other Name: Glidescope
Experimental: non obese patient Other: 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.
Other Name: Glidescope

Detailed Description:

Eighty-nine patients undergoing surgeries necessitating general anesthesia and tracheal intubation were enrolled in this study. Group 1 (OB) including obese patients (n= 59) was undergoing bariatric surgery. Following rapid sequence induction/intubation (RSII) anesthesia with cricoid pressure, clear view of the vocals cord and the entrance to the esophagus were assessed using Glidescope® video laryngoscope before intubation and following intubation. Following securing the airway, efficacy of cricoid pressure was tested by the capability to insert gastric tubes (20 and 38 Fr) under direct vision using GVL. Group 2 (NOB) including non-obese patients (n=30) was undergoing moderate surgery requiring tracheal intubation under general anesthesia. Efficacy of cricoid pressure was also tested similarly using GT's (20 and 38 Fr) following induction of anesthesia and before intubation. Inability of GT insertion was recorded as non-patent esophagus (effective CP) and successful insertion of GT was recorded as patent esophagus (ineffective CP). Then CP was released and insertion of GT achieved for correct verification of the esophageal opening position in both groups.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obese patients ( BMI 40-70 kg/m2)
  • No Contre indication to cricoid pressure
  • No-obese patients (BMI < 40)

Exclusion Criteria:

  • ASA 3 and 4
  • Contre indication to cricoid pressure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415661

Locations
Saudi Arabia
procare Riaya Hospital
Al Khobar, Estern, Saudi Arabia, 31952
Sponsors and Collaborators
Procare Riaya Hospital
Investigators
Study Chair: AHED ZEIDAN, MD Procare Riaya Hospital
  More Information

No publications provided

Responsible Party: Ahed ZEIDAN, MD, Procare Riaya Hospital
ClinicalTrials.gov Identifier: NCT01415661     History of Changes
Other Study ID Numbers: PRH 01
Study First Received: August 4, 2011
Last Updated: April 7, 2012
Health Authority: Saudi Arabia: Ethics Committee

ClinicalTrials.gov processed this record on April 14, 2014