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

Seoul National University

Status: Completed

Conditions: Intubation

Treatments: Device: Rotation technique group; Device: Standard technique group

Study type: Interventional

Funder types: Other

Identifiers

NCT01076725

SeoulNUBH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 3 to 9 years old

Volunteers: No Healthy Volunteers

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.

Trial design

63 participants in 2 patient groups

Standard technique group

Active Comparator group

Description:

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

Treatment:

Device: Standard technique group

Rotation technique group

Experimental group

Description:

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.

Treatment:

Device: Rotation technique group