Rotation Technique for the Insertion of the ProSeal Laryngeal Mask Airway in Pediatric Patients

Study Overview
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Brief Summary
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Insertion of the ProSeal laryngeal mask airway in pediatric patients using the 90 degree rotational technique is more successful and causes less pharyngeal trauma than the standard technique in pediatric patients.

Detailed Description
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In our previous series of studies, we introduced a new, simple and effective 90 degree rotational insertion technique and the insertion success rate was great and less pain occurred with the rotational technique in adult. In this study, we investigated whether the 90 degree rotational technique will improve the insertion success rate than the standard technique in pediatric patients. We hypothesized that the 90 degree rotational technique will improve the insertion success rate and decrease the complication of 2 to 3 size PLMA than the standard index finger insertion technique in children. One hundred twenty six Asian pediatric patients were randomly allocated to a standard technique group or rotation technique group. The size of the PLMA was from 2 to 3 according to body weight of children. In the standard technique group (n = 63), the PLMA was inserted by index finger insertion technique. In the rotation technique group (n = 63), 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 felt. The primary outcome was success at first insertion. Secondary outcome measures were insertion time and complications. Success at first insertion was significantly higher for the rotation technique than the standard technique, and significantly less time was required. With the rotation technique, the incidence of PLMA repositioning and blood staining was significantly less than for the standard technique. The rotational insertion technique for PLMA is more successful than the standard insertion technique and is associated with fewer blood staining on the PLMA which suggests that it causes less pharyngeal trauma in pediatric patients.

Official Title
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Insertion of the ProSeal Laryngeal Mask Airway is More Successful With the 90 Degree Rotation Technique in Pediatric Patients: a Randomized Controlled Trial

Conditions
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Intubation

Intervention / Treatment
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* Device: Standard technique group
* Device: Rotation technique group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asian pediatric patients (age range 3-9 years; American Society of Anesthesiologists physical status I-II) who required general anesthesia with a PLMA for elective surgery. Exclusion Criteria: Pediatric patient weighed less than 10 kg or over 50 kg, had congenital heart disease, respiratory disease or were at risk of aspiration.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 9 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 group<br>In the standard technique group(n = 63), the PLMA was inserted by index finger insertion technique. | Device: Standard technique group<br>* In the standard technique group (n = 63), the PLMA was inserted by index finger insertion technique.<br>* Other names: Digital insertion group;|
| Experimental: Rotation technique group<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 felt. | Device: Rotation technique group<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 felt.<br>* Other names: 90 degree rotation insertion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion success rate at first attempt | % of success at first trial | 5 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion time, sealing pressure and complication | Insertion time is an indices of the ease of insertion. Sealing pressure is an equilibrium airway pressure (maximum allowed = 40 cmH2O) when the expiratory valve of the breathing circuit was closed and a gas flow rate of 3 l/min was maintained. Blood on the surface of the cuff, incidence of postoperative sore throat or hoarseness are indices of complications. | 5 min-4 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ProSeal LMA, standard insertion, rotational insertion