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

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ClinicalTrials.gov Identifier: NCT01836419
Recruitment Status : Completed
First Posted : April 19, 2013
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief 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.


Condition or disease Intervention/treatment Phase
Minor Urologic Surgery Lower Extremity Surgery Procedure: classic LMA insertion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: young adult group
young adult patients undergoing minor urologic surgery or lower extremity surgery
Procedure: classic LMA insertion
Active Comparator: elderly group
elderly patients undergoing minor urologic surgery or lower extremity surgery
Procedure: classic LMA insertion



Primary Outcome Measures :
  1. oropharyngeal leak pressure [ Time Frame: 24 hours ]
    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.



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836419


Locations
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Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01836419    
Other Study ID Numbers: 4-2012-0711
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014
Keywords provided by Yonsei University:
classic laryngeal mask airway
elderly patients