The Influence of Degree of Head Elevation on Insertion Success for ProSeal Laryngeal Mask Airway Insertion

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Device: Insertion of ProSeal laryngeal mask airway

• Registration Number: NCT02058030
• Lead Sponsor: National Medical Center, Seoul

Brief Summary

Background - The purpose of the present study is to evaluate the success and pharyngeal trauma when 3 or 6 cm height of pillow is used for the ProSealTM laryngeal mask airway insertion

Methods

- This prospective randomized, controlled study included 80 adult patients . In the 3 cm (n=40) or 6 cm group (n=40), the PLMA was inserted while the head is placed on the 3 cm or 6 cm height of pillow. The success rate at first and second attempt, insertion time, blood staining on cuff, sore throat and hoarseness were assessed.

Detailed Description

Background: The "sniffing position" (i.e., the neck flexed and head extended by means of a pillow) eases tracheal intubation because the three axes, namely, the axis of the mouth, the pharyngeal axis and the laryngeal axis, are put in almost a straight line. The benefit of the sniffing position that align three axis could possibly be applicable when the ProSeal LMA is inserted. For the endotracheal intubation, it has been recommended to elevate the patient's head 8 to 10 cm with pads under the occiput (shoulder remaining on the table) and extend the head at the atlanto-occipital joint to align the oral, pharyngeal, and laryngeal axes such that the passage and line of vision from the lips to the glottic opening are most nearly a straight line.

There have been several clinical studies about the effect of head and neck position including neutral, flexion or extension on the ease of LMA insertion.

However, it has not been much recommended or investigated about the influence of head elevation on the insertion success of PLMA until now. The purpose of the present study is to evaluate the success and pharyngeal trauma when 3 or 6 cm height of pillow is used for the ProSeal laryngeal mask airway insertion in adult patients.

Study Timeline

• Study First Submitted: 2013-10-08
• Study Start: 2013-11
• Study First Submitted QC: 2014-02-06
• Study First Posted: 2014-02-07
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• American Society of Anesthesiologists physical status 1-2
• scheduled for minor surgery in the supine position were enrolled

Exclusion Criteria

• cardiorespiratory disease patients
• patients were at risk of aspiration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3cm head elevation	Insertion of ProSeal laryngeal mask airway	Insertion of ProSeal laryngeal mask airway
6cm head elevation	Insertion of ProSeal laryngeal mask airway	Insertion of ProSeal laryngeal mask airway

Primary Outcome Measures

Name	Time	Method
insertion success rate	2013.11 - 2014.12

Secondary Outcome Measures

Name	Time	Method
complication	2013.11- 2014.12	Number of participants with blood on the surface of the cuff, postoperative sore throat and hoarseness as indices of complications.

Trial Locations

Locations (1)

National Medical Center; 🇰🇷 Seoul, Korea, Republic of