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

NCT01076725 | Completed DMC

• 1 other identifier: SeoulNUBH
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intubation

Keywords

ProSeal LMA; standard insertion; rotational insertion

Outcome Measures

Primary Outcomes (1)

• Insertion success rate at first attempt

  % of success at first trial

  5 minute

Secondary Outcomes (1)

• Insertion time, sealing pressure and complication

  5 min-4 hrs

Study Arms (2)

Standard technique group

ACTIVE COMPARATOR

In the standard technique group(n = 63), the PLMA was inserted by index finger insertion technique.

Device: Standard technique group

Rotation technique group

EXPERIMENTAL

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

Interventions

Standard technique group DEVICE

In the standard technique group (n = 63), the PLMA was inserted by index finger insertion technique.

Also known as: Digital insertion group

Standard technique group

Rotation technique group DEVICE

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.

Also known as: 90 degree rotation insertion

Rotation technique group

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Pediatric patient weighed less than 10 kg or over 50 kg, had congenital heart disease, respiratory disease or were at risk of aspiration.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Related Publications (3)

• 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.

  PMID: 19293690 BACKGROUND

• 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.

  PMID: 20077171 BACKGROUND

• 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.

  PMID: 21203877 DERIVED

Study Officials

• Mija Yun, Professor

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: February 26, 2010
• Study Start: May 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 26, 2010

Record last verified: 2009-04