NCT01836419

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

11 months

First QC Date

April 16, 2013

Last Update Submit

February 17, 2014

Conditions

Minor Urologic SurgeryLower Extremity Surgery

Keywords

classic laryngeal mask airwayelderly patients

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

young adult group

EXPERIMENTAL

young adult patients undergoing minor urologic surgery or lower extremity surgery

Procedure: classic LMA insertion

elderly group

ACTIVE COMPARATOR

elderly patients undergoing minor urologic surgery or lower extremity surgery

Procedure: classic LMA insertion

Interventions

classic LMA insertionPROCEDURE
elderly groupyoung adult group

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Predicted difficult airway
  • Increased risk of aspiration
  • Gastroesophageal reflux
  • Neuromuscular disease
  • Significant acute or chronic lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, Seoul, 120-752, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2013

First Posted

April 19, 2013

Study Start

December 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

KR(1)