NCT01606956

Brief Summary

Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion in adult patients. However, it is not proven how much the cuff should be inflated. The aim of this study is to compare efficacy between the method using the resting volume and the method using half the maximum volume for partial cuff inflation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

1.2 years

First QC Date

May 22, 2012

Last Update Submit

March 4, 2014

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

  • The intra-cuff pressure

    After insertion of LMA, we confirm adequate ventilation. And then we measure intra-cuff pressure using cuff pressure manometer.

    approximately 5 to 10 minutes after insertion of LMA.

Secondary Outcomes (1)

  • leak volume

    approximately 5 to 10 minutes after insertion of LMA.

Study Arms (2)

resting volume group

EXPERIMENTAL
Procedure: The cuff inflation by the resting volume

half the maximum volume group

ACTIVE COMPARATOR
Procedure: The cuff inflation by half the maximum volume

Interventions

The cuff inflation by the resting volumePROCEDURE

80 patients are randomly allocated into two groups : resting volume group (n=40), half the maximum volume group (n=40). In the resting volume group, the pilot balloon valve is connected to syringe without piston for keeping the valve open to the atmosphere and allowing the pressure within the cuff of LMA to equalize with atmospheric pressure. In the half the maximum volume group, the cuff of LMA is completely emptied and then the cuff is filled with the half the maximum volume.

resting volume group
The cuff inflation by half the maximum volumePROCEDURE

80 patients are randomly allocated into two groups : resting volume group (n=40), half the maximum volume group (n=40). In the resting volume group, the pilot balloon valve is connected to syringe without piston for keeping the valve open to the atmosphere and allowing the pressure within the cuff of LMA to equalize with atmospheric pressure. In the half the maximum volume group, the cuff of LMA is completely emptied and then the cuff is filled with the half the maximum volume.

half the maximum volume group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients (20-70 years of age) scheduled for elective surgery undergoing general anesthesia using LMA-classic size 3-5

You may not qualify if:

  • patients with an abnormal airway,
  • patients with reactive airway disease,
  • patients with gastroesophageal reflux disease,
  • patients with chronic respiratory disease,
  • or a history of an upper respiratory tract infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (2)

  • Al-Shaikh B, George William M, Van Zundert AA. Using atmospheric pressure to inflate the cuff of the Portex Laryngeal Mask. Anaesthesia. 2005 Mar;60(3):296-7. doi: 10.1111/j.1365-2044.2005.04135.x. No abstract available.

    PMID: 15710025BACKGROUND

  • Kim MS, Lee JR, Shin YS, Chung JW, Lee KH, Ahn KR. Comparison of 2 cuff inflation methods of laryngeal mask airway Classic for safe use without cuff manometer in adults. Am J Emerg Med. 2014 Mar;32(3):237-42. doi: 10.1016/j.ajem.2013.11.029. Epub 2013 Nov 21.

    PMID: 24360025DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2012

First Posted

May 28, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations

KR(1)