The Clinical Efficacy of Laryngeal Mask Airway in Elderly Patients: Comparison With Young Adults

Lower Extremity Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836419
• Other study ID #: 4-2012-0711
• Status: Completed
• Phase: N/A
• First received: April 16, 2013
• Last updated: February 17, 2014
• Start date: December 2012
• Est. completion date: November 2013

Study information

• Verified date: February 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

There are some differences between elderly and young adult patients regarding the anatomy of upper airways. Elderly patients have larger upper airways than young adult patients at all pharyngeal levels as revealed by CT. Another study explained that there is a progressive descent of the larynx and epiglottis with aging, which lengthens the upper airway and possibly makes it more likely to collapse.

The aim of this study is to compare the clinical efficacy of laryngeal mask airway (LMA) in elderly patients with young adults. In this study, the investigators will measure the ease of insertion, success rate of insertion, the time of insertion, oropharyngeal leak pressure, gastric leak pressure, fiberoptic position and intraoperative complications of the classic LMA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients aged 20-40 and 65-85years

• ASA status 1-2

• Undergoing minor urologic surgery or lower extremity surgery

• Undergoing general anesthesia using classic LMA

Exclusion Criteria:

• Predicted difficult airway

• Increased risk of aspiration

• Gastroesophageal reflux

• Neuromuscular disease

• Significant acute or chronic lung disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lower Extremity Surgery
• Minor Urologic Surgery

Intervention

Procedure:
• classic LMA insertion

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oropharyngeal leak pressure	After successful placement of LMA, airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O(fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.	24 hours	No