Efficacy of Cricoid Pressure in Occluding the Esophageal Entrance: A Glidescope ® Study (CP)
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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 |
- 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 |
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 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 May 21, 2013