Comparison of the Vividtrac™ and Other Videolaryngoscopes in Clinical Practice

Comparison of Necessary Time for Successful Intubation With the Vividtrac™ and KingVision™ Videolaryngoscopes and Macintosh Blade Direct Laryngoscopy in Clinical Practice

Comparison of various videolaryngoscope devices (Vividtrac™ and KingVision™) and direct laryngoscopy with Macintosh blade regarding laryngoscopy time, intubation time, intubation success rate, percentage of visible glottic opening (POGO score) in elective and acute clinical anaesthesiology practice.

Study Overview

• Status: Unknown
• Conditions: Intubation;Difficult
• Intervention / Treatment: Device: Direct laryngoscopy; Device: KingVision videolaryngoscope; Device: Vividtrac videolaryngoscope

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Baranya county
    • Pécs, Baranya county, Hungary, 7622
      • Recruiting
      • University of Pécs, Dept. of Anaesthesia and Intensive Care
      • Sub-Investigator: Dóra Keresztes, MD
      • Principal Investigator: Gábor Woth, MD PhD
      • Sub-Investigator: Bálint Nagy, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• written informed consent
• over 18 years of age
• elective intervention
• no anticipated difficult airway or intubation
• preoperative anaesthesia risk assessment by American Society of Anaesthesiologists (ASA) physical status classification: ASA grade I-II

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Macintosh laryngoscopy; In this group intubation attempt is carried out with a standard Macintosh (size 3 or 4) direct laryngoscopy blade.	Device: Direct laryngoscopy; During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a size 4 (or size 3 if necessary) Macintosh blade direct laryngoscope.
Active Comparator: KingVision videolaryngoscope; In this group intubation attempt is carried out with KingVision videolaryngoscope with a channeled, disposable single-use blade.	Device: KingVision videolaryngoscope; During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a KingVision videolaryngoscope.
Active Comparator: VividTrac videolaryngoscope; In this group intubation attempt is carried out with VividTrac Adult model using a smartphone or laptop running the VividVision proprietary software.	Device: Vividtrac videolaryngoscope; During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a Vividtrac videolaryngoscope connected to a tablet or smartphone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation time	Time necessary to secure airway during the induction of general anesthesia. Intubation time is measured from the point the airway device crosses the interdental line until the completion of intubation with insufflated cuffed endotracheal tube (secured airway).	Measured once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laryngoscopy time	Time necessary to achieve best visualisation of the glottic opening.	Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
Percentage of glottic opening (POGO) score	The POGO score describes the best view of the glottic opening compared to the anatomical picture of the glottis. During direct laryngoscopy the investigator registers an approximate socre, while video laryngoscopy records are assessed by an independent investigator.	Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
Tube insertion time	Time necessary for the operator to insert the cuffed endotracheal tube inside the proximal part of the trachea through the glottic opening. Tube insertion time is measured after the investigator finished the search for the glottic opening, achieved best view and decided to insert the tube into the trachea until the cuff is inflated and the airway is secured.	Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
Primary intubation attempt success rate	All intubation attempts must be finished within 120 seconds or the investigator should give up the attempt and reoxygenize the patient before another attempt. If the investigator finished within the 120 seconds time frame we assess endotracheal tube position by capnography and auscultation. The attempt is regarded successful if the tube is in the right position and the airway is secured.	Measured once after intubation. Up to 120 seconds following the start of intubation attempt.

Collaborators and Investigators

• Sponsor: University of Pecs
• Investigators: Study Chair: Bálint Nagy, MD PhD, Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary; Study Chair: Szilárd Rendeki, MD, Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary; Study Chair: Lajos Bogár, MD PhD DSc, Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary

Publications and helpful links

General Publications

• Rendeki S, Keresztes D, Woth G, Merei A, Rozanovic M, Rendeki M, Farkas J, Muhl D, Nagy B. Comparison of VividTrac(R), Airtraq(R), King Vision(R), Macintosh Laryngoscope and a Custom-Made Videolaryngoscope for difficult and normal airways in mannequins by novices. BMC Anesthesiol. 2017 May 26;17(1):68. doi: 10.1186/s12871-017-0362-y.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 6328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No