NCT02897518

Brief Summary

The primary end point of this study is the feasibility of intubation. The secondary end-points are the success to intubate in the first attempt, the intubation time, the Cormack and Lehane score view, the comparison of the intubation difficulty scale (IDS) score and the need for maneuvers to aid the endotracheal intubation comparing Imago V-Blade ® and Glidescope®. Patients admit to the operation rooms of University of Naples "Federico II" and requiring endotracheal intubation for general anesthesia will be consecutively screened for the presence of predicted difficult airway according Italian guideline. According to this guideline, the presence of one or more of the following parameters may be considered highly predictive of difficult intubation: Mallampati class 3-4, inter-incisor distance \< 30 mm, mental-thyroidal distance \< 60 mm, large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust, reduced head and neck motility, and reduced mental-jugular distance. Patients matching more then 1 of the previous criteria stated by Italian guideline will be included in this case controlled study. Patients 1) without criteria for predicted difficult airway; 2) those requiring emergency surgery; 3) aged \< 18 years; or 4) declined consent to participate, will be excluded from this study.The primary end-point was the comparison of the intubation difficulty scale (IDS) score. The secondary end-points were the learning curve, the intubation time, the Cormack and Lehane score view, and the need for maneuvers to aid the endotracheal intubation comparing different videolaryngoscopes available in our department. Two anesthesiologists with 10 years of experience in conventional endotracheal intubation and trained for video assisted intubation will perform the maneuvers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

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

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

August 25, 2016

Last Update Submit

January 4, 2017

Conditions

Airway Management

Keywords

VideolaryngoscopesIntubation

Outcome Measures

Primary Outcomes (1)

  • feasibility of endotracheal intubation

    within 60 seconds

Secondary Outcomes (5)

  • Success rate of endotracheal intubation using Imago V-Blade compared with Glidescope

    wthin 120 seconds

  • Intubation time

    wthin 120 seconds

  • Cormack and Lehane score view

    During endotracheal intubation

  • use of adjunctive maneuvers to aid the endotracheal intubation

    During endotracheal intubation

  • Intubation difficulty scale score

    within 60 seconds

Study Arms (2)

endotracheal intubation with Imago V-blade

EXPERIMENTAL

Patients in this arm will receive endotracheal intubation with the Imago V-Blade videolaryngoscopes.

Device: Imago V-Balde

endotracheal intubation with Glidescope

ACTIVE COMPARATOR

Patients in this arm will receive endotracheal intubation with the glidescope videolaryngoscopes.

Device: Glidescope

Interventions

Imago V-BaldeDEVICE

the endotracheal intubation will be performed with videolaryngoscopes (imago V-Blade) according to the user manual

endotracheal intubation with Imago V-blade
GlidescopeDEVICE

the endotracheal intubation will be performed with videolaryngoscopes (Glidescope) according to the user manual

endotracheal intubation with Glidescope

Eligibility Criteria

Age18 Years - 77 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\>18 years
  • Mallampati class 3-4
  • inter-incisor distance \< 30 mm
  • mental-thyroidal distance \< 60 mm
  • large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust -reduced head and neck motility
  • reduced mental-jugular distance.

You may not qualify if:

  • \< 1 criteria for predicted difficult airway
  • emergency surgery
  • age \< 18 years
  • declined consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples Federico II department of Anesthesia and Critical Care

Naples, Italy, 80100, Italy

Location

Related Publications (1)

  • Vargas M, Pastore A, Aloj F, Laffey JG, Servillo G. A comparison of videolaryngoscopes for tracheal intubation in predicted difficult airway: a feasibility study. BMC Anesthesiol. 2017 Feb 20;17(1):25. doi: 10.1186/s12871-017-0318-2.

    PMID: 28219331DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 25, 2016

First Posted

September 13, 2016

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 5, 2017

Record last verified: 2017-01

Locations

IT(1)