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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01076725
First received: February 25, 2010
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Intubation
Device: Standard technique group
Device: Rotation technique group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Official Title: Insertion of the ProSeal Laryngeal Mask Airway is More Successful With the 90 Degree Rotation Technique in Pediatric Patients: a Randomized Controlled Trial

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Insertion success rate at first attempt [ Time Frame: 5 minute ] [ Designated as safety issue: Yes ]
    % of success at first trial


Secondary Outcome Measures:
  • Insertion time, sealing pressure and complication [ Time Frame: 5 min-4 hrs ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 63
Study Start Date: May 2009
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 90 degree rotation insertion

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.

  Eligibility

Ages Eligible for Study:   3 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01076725

Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Mija Yun, Professor Seoul National University Bundang Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01076725     History of Changes
Other Study ID Numbers: SeoulNUBH
Study First Received: February 25, 2010
Last Updated: February 25, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
ProSeal LMA
standard insertion
rotational insertion

ClinicalTrials.gov processed this record on October 01, 2014