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

Aspiration Clinical Trial

— CP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415661
• Other study ID #: PRH 01
• Status: Completed
• Phase: N/A
• First received: August 4, 2011
• Last updated: April 7, 2012
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: April 2012
• Source: Procare Riaya Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aspiration

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	procare Riaya Hospital	Al Khobar	Estern

Sponsors (1)

Lead Sponsor	Collaborator
Procare Riaya Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Cricoid Pressure for Prevention of Aspiration		24 hours	Yes