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The Rotational Insertion Technique for ProSeal Laryngeal Mask Airway

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00966186
First Posted: August 26, 2009
Last Update Posted: August 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Seoul National University Hospital
  Purpose
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.

Condition Intervention
General Anesthesia Elective Surgery Procedure: Insertion fo ProSeal laryngeal mask airway

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: The 90-degree Rotational Insertion Technique for the Large Size ProSeal Laryngeal Mask Airway

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Success of Insertion at First Attempt [ Time Frame: 5 minute ]

Secondary Outcome Measures:
  • Insertion Time, Sealing Pressure and Complication [ Time Frame: 5 min - 4 hours ]

Enrollment: 120
Study Start Date: November 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard technique
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
Insertion fo ProSeal laryngeal mask airway using each of Standard technique or Rotational technique
Experimental: 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
Procedure: Insertion fo ProSeal laryngeal mask airway
Insertion fo ProSeal laryngeal mask airway using each of Standard technique or 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   27 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966186


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Kyonggi, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jung-won Hwang, MD Seoul National University Bundang Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jung-won Hwang, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00966186     History of Changes
Other Study ID Numbers: jungwon
First Submitted: August 20, 2009
First Posted: August 26, 2009
Results First Submitted: January 4, 2010
Results First Posted: August 16, 2010
Last Update Posted: August 16, 2010
Last Verified: July 2010

Keywords provided by Seoul National University Hospital:
ProSeal Laryngeal Mask Airway
Rotational technique
Success rate
Postoperative complications