NCT01003327

Brief Summary

The intention of this study is to compare the performance of the single-use I-gel laryngeal mask with the classic laryngeal mask in 50 patients with a BMI\>25 during elective surgery. Primary outcome is the leak pressure. Secondary outcomes include ease and duration of insertion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 surgery

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_4 surgery

Geographic Reach
1 country

1 active site

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

October 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

July 23, 2010

Status Verified

October 1, 2009

Enrollment Period

5 months

First QC Date

October 27, 2009

Last Update Submit

July 22, 2010

Conditions

SurgeryIntubation

Keywords

laryngeal mask, leak pressureleak pressure

Outcome Measures

Primary Outcomes (1)

  • leak pressure of the laryngeal masks

    directly after insertion of the laryngeal mask

Secondary Outcomes (1)

  • Insertion time and ease of insertion of the laryngeal mask

    during insertion of the laryngeal mask

Study Arms (2)

I-gel inserted first

OTHER

The I-gel airway is insewrted first, then the LMA-Unique

Device: I-gel

LMA-Unique inserted first

OTHER

LMA-Unique airway is inserted first, then the I-gel

Device: LMA-Unique

Interventions

I-gelDEVICE

intubation with I-gel airway

I-gel inserted first
LMA-UniqueDEVICE

LMA-Unique airway is inserted first, then the I-gel

LMA-Unique inserted first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 25, elective surgery in supine position,
  • age \> 18 years,
  • ASA I-II;

You may not qualify if:

  • difficult airway, pregnancy,
  • history of reflux or gastrointestinal disorders,
  • abdominal or thoracic surgery;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical university of vienna, General hospital of Vienna

Vienna, Vienna, 1090, Austria

Location

Study Officials

  • Ulrike Weber, M.D.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 28, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

July 23, 2010

Record last verified: 2009-10

Locations

AU(1)