NCT01814306

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

March 19, 2013

Status Verified

March 1, 2013

Enrollment Period

1.5 years

First QC Date

February 12, 2013

Last Update Submit

March 15, 2013

Conditions

Inadequate or Impaired Breathing Pattern or Ventilation

Keywords

LMA Supreme,LMA Proseal,airway management,prone position

Outcome Measures

Primary Outcomes (1)

  • Success rate of insertion (quality of ventilation)

    1 year

Secondary Outcomes (1)

  • Ease of insertion, Complication and Glottic seal pressure

    1 year

Study Arms (2)

Supreme

ACTIVE COMPARATOR

Supreme LMA

Device: Supreme LMA

Proseal

ACTIVE COMPARATOR

Proseal LMA

Device: Proseal LMA

Interventions

Supreme LMADEVICE

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

Supreme
Proseal LMADEVICE

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

Proseal

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chatchai Prechawai

    Prince of Songkla University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology Department

Study Record Dates

First Submitted

February 12, 2013

First Posted

March 19, 2013

Study Start

October 1, 2011

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

March 19, 2013

Record last verified: 2013-03

Locations

TH(1)