The Comparison of Two Different Methods of Partial Inflation of Cuff for Facile Insertion of Laryngeal Mask Airway in Adult Patients

NCT ID: NCT01606956

Last Updated: 2014-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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resting volume group

Group Type EXPERIMENTAL

The cuff inflation by the resting volume

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

The cuff inflation by half the maximum volume

Intervention Type PROCEDURE

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.

Interventions

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The cuff inflation by the resting volume

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.

Intervention Type PROCEDURE

The cuff inflation by half the maximum volume

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 15710025 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24360025 (View on PubMed)

Other Identifiers

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1-2012-0012

Identifier Type: -

Identifier Source: org_study_id

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