NCT01425151

Brief Summary

In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the i-GelTM in anesthetized pediatric patients.

Trial Health

90
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 2010

Geographic Reach
2 countries

2 active sites

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

January 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2011

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 22, 2011

Status Verified

September 1, 2011

Enrollment Period

1.7 years

First QC Date

August 26, 2011

Last Update Submit

September 20, 2011

Conditions

Device Success RateDevice Performance

Outcome Measures

Primary Outcomes (1)

  • Oropharyngeal leak pressure

    10 Minutes

Secondary Outcomes (1)

  • Insertion success rate

    1 Minute

Study Arms (2)

i-Gel

ACTIVE COMPARATOR
Device: i-Gel

ProSeal

EXPERIMENTAL
Device: ProSeal

Interventions

i-GelDEVICE

Oropharyngeal leak pressure Insertion success

i-Gel
ProSealDEVICE

Oropharyngeal leak pressure Insertion success

ProSeal

Eligibility Criteria

Age18 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA I and II
  • Age 1.5-6 years

You may not qualify if:

  • known or predicted difficult airway
  • body mass index \> 35 kg m-2
  • risk of aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinik für Anästhesie und Allgemeine Intensivmedizin

Innsbruck, 6020, Austria

Location

Christian Keller

Zurich, 8008, Switzerland

Location

Study Officials

  • Christian Keller, MD, M.Sc.

    Schulthess Klinik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, M.Sc.

Study Record Dates

First Submitted

August 26, 2011

First Posted

August 29, 2011

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 22, 2011

Record last verified: 2011-09

Locations

AU(1)CH(1)