The Rotational Insertion Technique for ProSeal Laryngeal Mask Airway

Not Applicable

Completed

• Conditions: General Anesthesia; Elective Surgery
• Interventions: Procedure: Insertion fo ProSeal laryngeal mask airway

• Registration Number: NCT00966186
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to compare two insertion techniques of large size ProSeal laryngeal mask airway. We hypothesized that insertion of ProSeal laryngeal mask airway with 90-degree rotation would reduce the contact surface between the device and pharyngeal wall and make it easy to advance the device over the smooth angle against the posterior pharyngeal wall.We compared the success rate and incidence of complication of the standard technique with the rotational technique.

Detailed Description

ProSeal laryngeal mask airway is not easy to be inserted due to its larger cuff especially in Asian population. First-time insertion success rate was lower and more time was required to achieve an effective airway even in well-trained physician. A number of techniques have been described to improve the insertion success rate. However, these techniques are only recommended to be used as backup when the digital or introducer tool techniques fail. We hypothesized that insertion of ProSeal laryngeal mask airway with 90-degree rotation would reduce the contact surface between the device and pharyngeal wall and make it easy to advance the device over the smooth angle against the posterior pharyngeal wall.We compared the success rate and incidence of complication of the standard technique with the rotational technique.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Study First Submitted: 2009-08-20
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-26
• Results First Submitted: 2010-01-04
• Status Verified: 2010-07
• Results First Submitted QC: 2010-07-21
• Last Update Submitted: 2010-07-21
• Results First Posted: 2010-08-16
• Last Update Posted: 2010-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• American Society of Anesthesiologists physical status I-II

Exclusion Criteria

• Predicted difficult airway
• Mouth opening less than 2.5 cm
• Present sore throat
• High risk of aspiration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotational technique	Insertion fo ProSeal laryngeal mask airway	The entire cuff of the PLMA was placed in the mouth without finger insertion in a midline approach and was rotated 90 degrees counterclockwise around the tongue. The PLMA was then advanced and rotated back until resistance was fel
Standard technique	Insertion fo ProSeal laryngeal mask airway	Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual (insertion with help of index finger insertion)

Primary Outcome Measures

Name	Time	Method
Success of Insertion at First Attempt	5 minute

Secondary Outcome Measures

Name	Time	Method
Insertion Time, Sealing Pressure and Complication	5 min - 4 hours

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Kyonggi, Korea, Republic of