The Rotational Insertion Technique for ProSeal Laryngeal Mask Airway

NCT ID: NCT00966186

Last Updated: 2010-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-05-31

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.

Conditions

General Anesthesia; Elective Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Standard technique

Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual (insertion with help of index finger insertion)

Group Type: ACTIVE_COMPARATOR

Insertion fo ProSeal laryngeal mask airway

Intervention Type: PROCEDURE

Insertion fo ProSeal laryngeal mask airway using each of Standard technique or Rotational technique

Rotational technique

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

Group Type: EXPERIMENTAL

Insertion fo ProSeal laryngeal mask airway

Intervention Type: PROCEDURE

Insertion fo ProSeal laryngeal mask airway using each of Standard technique or Rotational technique

Interventions

Insertion fo ProSeal laryngeal mask airway

Insertion fo ProSeal laryngeal mask airway using each of Standard technique or Rotational technique

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 27 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seoul National University Bundang Hospital

Principal Investigators

Jung-won Hwang, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

References

Jeon YT, Na HS, Park SH, Oh AY, Park HP, Yun MJ, Kim JH, Hwang JW. Insertion of the ProSeal laryngeal mask airway is more successful with the 90 degrees rotation technique. Can J Anaesth. 2010 Mar;57(3):211-5. doi: 10.1007/s12630-009-9241-4. Epub 2010 Jan 15.

Reference Type: DERIVED

PMID: 20077171 (View on PubMed)

Other Identifiers

jungwon

Identifier Type: -

Identifier Source: org_study_id