NCT02252120

Brief Summary

The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LMA SupremeTM and the Laryngeal Tube LTS IITM in non-paralyzed anaesthetized pediatric patients

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
Last Updated

September 29, 2014

Status Verified

September 1, 2014

Enrollment Period

8 months

First QC Date

September 17, 2014

Last Update Submit

September 26, 2014

Conditions

Adverse Anesthesia Outcome

Outcome Measures

Primary Outcomes (1)

  • Oropharyngeal leak pressure

    Oropharyngeal leak pressure was determined by closing the expiratory valve of the anaesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).

    5 Min

Secondary Outcomes (1)

  • Fiberoptic position

    5 Min

Other Outcomes (1)

  • Ease of insertion

    1 Min

Study Arms (2)

Supreme

ACTIVE COMPARATOR

Supreme LMA

Device: SupremeDevice: Laryngeal Tube

Laryngeal Tube

ACTIVE COMPARATOR

Laryngeal tube LTSII

Device: SupremeDevice: Laryngeal Tube

Interventions

SupremeDEVICE
Laryngeal TubeSupreme
Laryngeal TubeDEVICE
Laryngeal TubeSupreme

Eligibility Criteria

Age18 Months - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA I-II
  • age 1.5 - 9 years
  • minor surgery
  • extraglottic airway device

You may not qualify if:

  • age (\<18 months, \>9 years)
  • weight (\<10 kg, \>25 kg)
  • a known difficult airway
  • risk of aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Christian Keller, MD, M.Sc.

    Schulthess Klinik, Lengghalde 2, 8008 Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. M.Sc.

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 29, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 29, 2014

Record last verified: 2014-09