The Rotational Insertion Technique for ProSeal Laryngeal Mask Airway

General Anesthesia Clinical Trial

Official title:

The 90-degree Rotational Insertion Technique for the Large Size ProSeal Laryngeal Mask Airway

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966186
• Other study ID #: jungwon
• Status: Completed
• Phase: N/A
• First received: August 20, 2009
• Last updated: July 21, 2010
• Start date: November 2008
• Est. completion date: May 2009

Study information

• Verified date: July 2010
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 27 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Elective Surgery
• General Anesthesia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of Insertion at First Attempt		5 minute	Yes
Secondary	Insertion Time, Sealing Pressure and Complication		5 min - 4 hours	Yes