The Rotational Insertion Technique for ProSeal Laryngeal Mask Airway

NCT00966186 | Completed Results DMC

• 1 other identifier: jungwon
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia; Elective Surgery

Keywords

ProSeal Laryngeal Mask Airway; Rotational technique; Success rate; Postoperative complications

Outcome Measures

Primary Outcomes (1)

• Success of Insertion at First Attempt

  5 minute

Secondary Outcomes (1)

• Insertion Time, Sealing Pressure and Complication

  5 min - 4 hours

Study Arms (2)

Standard technique

ACTIVE COMPARATOR

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

Procedure: Insertion fo ProSeal laryngeal mask airway

Rotational technique

EXPERIMENTAL

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

Procedure: Insertion fo ProSeal laryngeal mask airway

Interventions

Insertion fo ProSeal laryngeal mask airway PROCEDURE

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

Rotational technique; Standard technique

Eligibility Criteria

• Age: 27 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical status I-II

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

Related Publications (1)

• 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.

  PMID: 20077171 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

First, as the PLMAs were inserted by two anesthesiologists who were experts in PLMA insertion, these results may not apply to novices. Second, the insertion technique was impossible to blind the anesthesiologists, which might be a source of bias.

Results Point of Contact

• Title: Jung-Won Hwang
• Organization: Seoul National University Bundang Hospital

jungwon@snubh.org

82-31-787-7499

Study Officials

• Jung-won Hwang, MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 26, 2009
• Study Start: November 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 16, 2010
• Results First Posted: August 16, 2010

Record last verified: 2010-07

Locations

KR (1)