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

• Sponsor: Procare Riaya Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01415661
• Collaborator: (none)
• Enrollment: 89
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 11.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Aspiration	Other: cricoid pressure	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 89 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Efficacy of Cricoid Pressure in Occluding the Esophageal Entrance: A Glidescope ® Study
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Efficacy of Cricoid Pressure for Prevention of Aspiration [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	procare Riaya Hospital	Al Khobar	Estern	Saudi Arabia	31952

Sponsors and Collaborators

• Procare Riaya Hospital

Investigators

• Study Chair: AHED ZEIDAN, MD, Procare Riaya Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahed ZEIDAN, MD, Procare Riaya Hospital
• ClinicalTrials.gov Identifier: NCT01415661
• Other Study ID Numbers: PRH 01
• First Posted: Aug 12, 2011
• Last Update Posted: Apr 10, 2012
• Last Verified: Apr 1, 2012

Study Results

No Results Posted as of Apr 10, 2012