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

Anesthesia Clinical Trial

Official title:

The 3 cm of Head Elevation Provides Higher Insertion Success Than do the 6 cm of it for ProSeal Laryngeal Mask Airway Insertion in Adult Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02058030
• Other study ID #: phdkim1
• Status: Completed
• Phase: N/A
• First received: October 8, 2013
• Last updated: August 5, 2015
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: National Medical Center, Seoul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Insertion of ProSeal laryngeal mask airway
The patient's head was placed on the 3 cm or 6 cm height of a pillow in supine and PLMA was inserted using a standard method in the sniffing position. The success rate at first and second attempt, insertion time, Seal pressure, hemodynamic variables, complications(blood staining on cuff, sore throat and hoarseness) were assessed

Locations

Country	Name	City	State
Korea, Republic of	National Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
National Medical Center, Seoul

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insertion success rate		2013.11 - 2014.12	Yes
Secondary	complication	Number of participants with blood on the surface of the cuff, postoperative sore throat and hoarseness as indices of complications.	2013.11- 2014.12	Yes