Supreme LMA and Proseal LMA in Prone Anesthetized Patient

Inadequate or Impaired Breathing Pattern or Ventilation Clinical Trial

— SPLMA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01814306
• Other study ID #: SPLMA-100
• Secondary ID: SPLMA-100-CPrech
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 12, 2013
• Last updated: March 15, 2013
• Start date: October 2011
• Est. completion date: June 2013

Study information

• Verified date: March 2013
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

Inclusion Criteria:

• American Society Anesthesiologists physical status I-III

• Patient undergo elective orthopedics surgery in prone position under general anaesthesia

Exclusion Criteria:

• Age <15year

• Non-fast

• Morbid obesity (BMI > 35kg/m2)

• Pregnancy

• Known or predicted difficult airway

• GERD

• History of laryngeal problem (injury,subglottic stenosis)

• Local pharyngeal problem (abscess,tumor)

• Poor dentation

• Pulmonary disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Inadequate or Impaired Breathing Pattern or Ventilation

Intervention

Device:
• Supreme LMA
Use Supreme LMA to compare efficay with Proseal LMA in prone position insertion
• Proseal LMA
Use Proseal LMA to compare efficay with Supreme LMA in prone position insertion

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Prince of Songkla University	Had yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of insertion (quality of ventilation)		1 year	Yes
Secondary	Ease of insertion, Complication and Glottic seal pressure		1 year	Yes