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

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation
• Intervention / Treatment: Device: Standard technique group; Device: Rotation technique group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 9 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard technique group; In the standard technique group(n = 63), the PLMA was inserted by index finger insertion technique.	Device: Standard technique group; In the standard technique group (n = 63), the PLMA was inserted by index finger insertion technique.; Other Names: Digital insertion group
EXPERIMENTAL: Rotation technique group; 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; 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.; Other Names: 90 degree rotation insertion

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Mija Yun, Professor, Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• Hwang JW, Park HP, Lim YJ, Do SH, Lee SC, Jeon YT. Comparison of two insertion techniques of ProSeal laryngeal mask airway: standard versus 90-degree rotation. Anesthesiology. 2009 Apr;110(4):905-7. doi: 10.1097/ALN.0b013e31819b5d40.
• Jeon YT, Na HS, Park SH, Oh AY, Park HP, Yun MJ, Kim JH, Hwang JW. Insertion of the ProSeal laryngeal mask airway is more successful with the 90 degrees rotation technique. Can J Anaesth. 2010 Mar;57(3):211-5. doi: 10.1007/s12630-009-9241-4. Epub 2010 Jan 15.
• Yun MJ, Hwang JW, Park SH, Han SH, Park HP, Kim JH, Jeon YT, Lee SC. The 90 degrees rotation technique improves the ease of insertion of the ProSeal laryngeal mask airway in children. Can J Anaesth. 2011 Apr;58(4):379-83. doi: 10.1007/s12630-010-9452-8. Epub 2011 Jan 4.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ACTUAL): August 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: February 25, 2010
• First Submitted That Met QC Criteria: February 25, 2010
• First Posted (ESTIMATE): February 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 26, 2010
• Last Update Submitted That Met QC Criteria: February 25, 2010
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: ProSeal LMA; standard insertion; rotational insertion
• Other Study ID Numbers: SeoulNUBH