NCT00888875

Brief Summary

We evaluate feasibility of fiberoptic intubation through the "ILMA Fastrach" vs the "i-gel". Both are airway devices to be introduced in the mouth we the possibility to ventilate the patient and furthermore to be a guide to introduce a tracheal tube. We first insert either the ILMA or the i-gel. In a second step, we will introduce a tube through the device, all guided visually through a fiberoptic tool which works as a railroad for the tracheal tube.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

March 12, 2014

Status Verified

March 1, 2014

Enrollment Period

1.8 years

First QC Date

April 27, 2009

Last Update Submit

March 11, 2014

Conditions

Tracheal Intubation

Keywords

i-gelFastrachintubationfiberopticdifficult airwayPatients undergoing elective surgery requiring tracheal intubationPresenting at least one sign of difficult intubation

Outcome Measures

Primary Outcomes (1)

  • successful intubation attempt with ventilation of both lungs

    during intervention

Secondary Outcomes (2)

  • insertion of supraglottic airway devices, the time to intubate, airway device leak pressure, adverse events and postoperative side effects

    during intervention and first 24hours after operation

  • simulated blind intubation in both groups

    during intervention

Study Arms (2)

1

EXPERIMENTAL

Computer randomized insertion of the i-gel. Intubation fiberoptically of a tracheal tube

Device: i-gel

2

ACTIVE COMPARATOR

Computer randomized insertion of the i-gel. Intubation fiberoptically of a tracheal tube

Device: ILMA

Interventions

i-gelDEVICE

insertion after induction of anaesthesia. Afterwards, intubation over the device fiberoptically

1
ILMADEVICE

Insertion after Induction. Insertion of tracheal tube over device

2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective operation with intubation
  • ASA I-IV
  • speaks German
  • at least one predictor for difficult intubation

You may not qualify if:

  • weight \<30kg
  • Risk Aspiration
  • Risk bleeding orally
  • known or highly suspected difficult mask ventilation
  • Mouth opening \< 20mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Bern, Canton of Bern, 3010, Switzerland

Location

Study Officials

  • Robert Greif, M.D.

    Department of Anesthesia, University Hospital Berne, Switzerland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 28, 2009

Study Start

July 1, 2008

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

March 12, 2014

Record last verified: 2014-03

Locations

CH(1)