Clinical Trials Directory

Trials / Completed

CompletedNCT01076725

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
63 (actual)
Sponsor
Seoul National University Bundang Hospital · Academic / Other
Sex
All
Age
3 Years – 9 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DEVICEStandard technique groupIn the standard technique group (n = 63), the PLMA was inserted by index finger insertion technique.
DEVICERotation technique groupThe 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.

Timeline

Start date
2009-05-01
Primary completion
2009-08-01
Completion
2009-12-01
First posted
2010-02-26
Last updated
2010-02-26

Source: ClinicalTrials.gov record NCT01076725. Inclusion in this directory is not an endorsement.