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Completed

NCT Number: NCT02897518

Videolaryngoscopes for Tracheal Intubation

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.

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Key information

Conditions

Age range

18 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Naples Federico II department of Anesthesia and Critical Care

Naples, Italy, 80100

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Imago V-Balde

Device

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

Glidescope

Device

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

Primary outcomes

  1. feasibility of endotracheal intubation

    Time frame: within 60 seconds

Secondary outcomes

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

    Time frame: wthin 120 seconds

    Time to reach a successful endotracheal intubation from the beginning of indirect laryngoscopy to the confirmation of the intubation with the evaluation of the end-tidal carbon dioxide

  2. Intubation time

    Time frame: wthin 120 seconds

    time to reach endotracheal intubation from the beginning of indirect laryngoscopy to the confirmation of the intubation with the evaluation of the end-tidal carbon dioxide

  3. Cormack and Lehane score view

    Time frame: During endotracheal intubation

  4. use of adjunctive maneuvers to aid the endotracheal intubation

    Time frame: During endotracheal intubation

    the investigators evaluated the necessary maneuvers to aid a successful endotracheal intubation as number of Readjusting patient's head, number of external laryngeal pressure, number of advancement or withdrawal the blade and number of increased lifting force

  5. Intubation difficulty scale score

    Time frame: within 60 seconds

    Time to pass the vocal cord during the successful endotracheal intubation measured from the beginning of indirect laryngoscopy to the confirmation of the intubation with the evaluation of the end-tidal carbon dioxide

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Comparison Between Imago V-Blade and Glidescope During Endotracheal Intubation: a Feasibility Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 13, 2016
Registry last updated
Jan 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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