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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606956
• Other study ID #: 1-2012-0012
• Status: Completed
• Phase: N/A
• First received: May 22, 2012
• Last updated: March 4, 2014
• Start date: May 2012
• Est. completion date: July 2013

Study information

• Verified date: March 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator)

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	leak volume	After confirming adequate ventilation, tidal volumes are measured using spirometer sensor attached anesthesia machine. Five corresponding inspiratory and expiratory tidal volumes are recorded and the difference between these is calculated as the leak volume.	approximately 5 to 10 minutes after insertion of LMA.	No