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

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).

Study Overview

• Status: Completed
• Conditions: Aspiration
• Intervention / Treatment: Other: cricoid pressure

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Estern
    • Al Khobar, Estern, Saudi Arabia, 31952
      • Procare Riaya Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Glidescope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of Cricoid Pressure for Prevention of Aspiration	24 hours

Collaborators and Investigators

• Sponsor: Procare Riaya Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: August 4, 2011
• First Submitted That Met QC Criteria: August 11, 2011
• First Posted (ESTIMATE): August 12, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 10, 2012
• Last Update Submitted That Met QC Criteria: April 7, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: PRH 01