NCT02286570

Brief Summary

Trauma victims had to be intubated at the scene of area in different conditions. Face-to-face intubation in an entrapped patient is one of these situations. The investigators want to compare the efficacy of Glidescope, Airtraq and Fastrach in simulating face-ro-face intubation in adult patients aged between 18-60 years.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_4

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

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

2 months

First QC Date

October 31, 2014

Last Update Submit

March 31, 2015

Conditions

Intubation Difficult

Outcome Measures

Primary Outcomes (1)

  • intubation time

    2 minutes

    elapsing between the handling of the device till intubation 2 minutes

Secondary Outcomes (4)

  • mucosal damage

    blood on the device after removal 1 minute

  • postoperative minor complications sore troat, teeth damage, tongue damage, desaturation, hoarseness, disphagia

    sore troat, teeth damage, tongue damage, desaturation, hoarseness, disphagia 30 minutes

  • need of optimisation maneuvers

    chandy, side-to-side, handling force, up-down, reinserting 15 minutes

  • hemodynamic changes (mean arteriial pressure)

    entübation and after 15 minutes

Study Arms (3)

face-to-face intubation of Glidescope

ACTIVE COMPARATOR

patients were intubated using glidescope by face-to-face approach

Device: Glidescope

face-to-face intubation with Airtraq

ACTIVE COMPARATOR

patients were intubated using the Airtraq by face-to-face approach

Device: Airtraq

face-to-face intubation with fastrach

ACTIVE COMPARATOR

patients were intubated using the Fastrach by face-to-face approach

Device: Fastrach

Interventions

GlidescopeDEVICE

videolaryngoscope used for endotracheal intubation

face-to-face intubation of Glidescope
AirtraqDEVICE

videolaryngoscope used for endotracheal intubation

face-to-face intubation with Airtraq
FastrachDEVICE

intubating laryngeal mask airway used for blind endotracheal intubation

face-to-face intubation with fastrach

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • Elective surgery requiring endotracheal intubation
  • Normal airway variables
  • BMI\< 30

You may not qualify if:

  • \< 18 years or \> 60 years
  • Emergency procedures
  • Known difficult airways
  • BMI\> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Zehra I ARSLAN, Doctor

    Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 10, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

April 1, 2015

Record last verified: 2015-03