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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00966186
Other study ID # jungwon
Secondary ID
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


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
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