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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01836419
Other study ID # 4-2012-0711
Secondary ID
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


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
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