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Clinical Trials/NCT01814306
NCT01814306UnknownNot Applicable

Comparison of the Effectiveness Between the LMA SupremeTM and the LMA ProsealTM for Airway Management in Patient Undergoing Elective Orthopaedic Surgery in Prone Position

Prince of Songkla University2 sites in 1 country100 target enrollmentStarted: October 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
2
Primary Endpoint
Success rate of insertion (quality of ventilation)

Study Overview

Brief Summary

There is no significant difference about success rate of two devices.

Detailed Description

There is no significant difference about success rate of two device: efficacy and safety

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
— to 15 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • American Society Anesthesiologists physical status I-III
  • Patient undergo elective orthopedics surgery in prone position under general anaesthesia

Exclusion Criteria

  • Age <15year
  • Morbid obesity (BMI > 35kg/m2)
  • Pregnancy
  • Known or predicted difficult airway
  • History of laryngeal problem (injury,subglottic stenosis)
  • Local pharyngeal problem (abscess,tumor)
  • Poor dentation
  • Pulmonary disease

Outcomes

Primary Outcomes

Success rate of insertion (quality of ventilation)

Time Frame: 1 year

Secondary Outcomes

  • Ease of insertion, Complication and Glottic seal pressure(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chatchai Prechawai

Anesthesiology Department

Prince of Songkla University

Study Sites (2)

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