The Influence of Degree of Head Elevation on Insertion Success for ProSeal Laryngeal Mask Airway Insertion

Study Overview
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Brief Summary
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Background - The purpose of the present study is to evaluate the success and pharyngeal trauma when 3 or 6 cm height of pillow is used for the ProSealTM laryngeal mask airway insertion Methods - This prospective randomized, controlled study included 80 adult patients . In the 3 cm (n=40) or 6 cm group (n=40), the PLMA was inserted while the head is placed on the 3 cm or 6 cm height of pillow. The success rate at first and second attempt, insertion time, blood staining on cuff, sore throat and hoarseness were assessed.

Detailed Description
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Background: The sniffing position (i.e., the neck flexed and head extended by means of a pillow) eases tracheal intubation because the three axes, namely, the axis of the mouth, the pharyngeal axis and the laryngeal axis, are put in almost a straight line. The benefit of the sniffing position that align three axis could possibly be applicable when the ProSeal LMA is inserted. For the endotracheal intubation, it has been recommended to elevate the patient's head 8 to 10 cm with pads under the occiput (shoulder remaining on the table) and extend the head at the atlanto-occipital joint to align the oral, pharyngeal, and laryngeal axes such that the passage and line of vision from the lips to the glottic opening are most nearly a straight line. There have been several clinical studies about the effect of head and neck position including neutral, flexion or extension on the ease of LMA insertion. However, it has not been much recommended or investigated about the influence of head elevation on the insertion success of PLMA until now. The purpose of the present study is to evaluate the success and pharyngeal trauma when 3 or 6 cm height of pillow is used for the ProSeal laryngeal mask airway insertion in adult patients.

Official Title
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The 3 cm of Head Elevation Provides Higher Insertion Success Than do the 6 cm of it for ProSeal Laryngeal Mask Airway Insertion in Adult Patients

Conditions
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Anesthesia

Intervention / Treatment
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* Device: Insertion of ProSeal laryngeal mask airway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status 1-2 scheduled for minor surgery in the supine position were enrolled Exclusion Criteria: cardiorespiratory disease patients patients were at risk of aspiration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Other: 3cm head elevation<br>Insertion of ProSeal laryngeal mask airway | Device: Insertion of ProSeal laryngeal mask airway<br>* The patient's head was placed on the 3 cm or 6 cm height of a pillow in supine and PLMA was inserted using a standard method in the sniffing position. The success rate at first and second attempt, insertion time, Seal pressure, hemodynamic variables, complications(blood staining on cuff, sore throat and hoarseness) were assessed<br>|
| Active Comparator: 6cm head elevation<br>Insertion of ProSeal laryngeal mask airway | Device: Insertion of ProSeal laryngeal mask airway<br>* The patient's head was placed on the 3 cm or 6 cm height of a pillow in supine and PLMA was inserted using a standard method in the sniffing position. The success rate at first and second attempt, insertion time, Seal pressure, hemodynamic variables, complications(blood staining on cuff, sore throat and hoarseness) were assessed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insertion success rate |  | 2013.11 - 2014.12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication | Number of participants with blood on the surface of the cuff, postoperative sore throat and hoarseness as indices of complications. | 2013.11- 2014.12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ProSeal laryngeal mask airway, Insertion success, complication