The Rotational Insertion Technique for ProSeal Laryngeal Mask Airway

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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General Anesthesia, Elective Surgery

Intervention / Treatment
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* Procedure: Insertion fo ProSeal laryngeal mask airway


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 27 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard technique<br>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<br>* Insertion fo ProSeal laryngeal mask airway using each of Standard technique or Rotational technique<br>|
| Experimental: Rotational technique<br>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<br>* Insertion fo ProSeal laryngeal mask airway using each of Standard technique or Rotational technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of Insertion at First Attempt |  | 5 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion Time, Sealing Pressure and Complication |  | 5 min - 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ProSeal Laryngeal Mask Airway, Rotational technique, Success rate, Postoperative complications