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

Sponsor
National Medical Center, Seoul (Other)
Overall Status
Completed
CT.gov ID
NCT02058030
Collaborator
(none)
80
1
2
13
6.2

Study Details

Study Description

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.
Condition or Disease Intervention/Treatment Phase
  • Device: Insertion of ProSeal laryngeal mask airway
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
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
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: 3cm head elevation

Insertion of ProSeal laryngeal mask airway

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

Active Comparator: 6cm head elevation

Insertion of ProSeal laryngeal mask airway

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

Outcome Measures

Primary Outcome Measures

  1. insertion success rate [2013.11 - 2014.12]

Secondary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Medical Center Seoul Korea, Republic of 100-799

Sponsors and Collaborators

  • National Medical Center, Seoul

Investigators

  • Study Chair: Mija Yun, MD, PhD, National Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sung Hoon Kim, MD, National Medical Center, Seoul
ClinicalTrials.gov Identifier:
NCT02058030
Other Study ID Numbers:
  • phdkim1
First Posted:
Feb 7, 2014
Last Update Posted:
Aug 7, 2015
Last Verified:
Aug 1, 2015
Keywords provided by Sung Hoon Kim, MD, National Medical Center, Seoul

Study Results

No Results Posted as of Aug 7, 2015