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

NCT ID: NCT01415661

Last Updated: 2012-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-09-30

Brief Summary

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).

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.

Conditions

Aspiration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

obese patient

Group Type: EXPERIMENTAL

cricoid pressure

Intervention Type: OTHER

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.

non obese patient

Group Type: EXPERIMENTAL

cricoid pressure

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Glidescope

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Procare Riaya Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahed ZEIDAN

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHED ZEIDAN, MD

Role: STUDY_CHAIR

Procare Riaya Hospital

Locations

procare Riaya Hospital

Khobar, Estern, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

PRH 01

Identifier Type: -

Identifier Source: org_study_id