Comparison of the Vividtrac™ and Other Videolaryngoscopes in Clinical Practice

NCT03271008 | Unknown

• 1 other identifier: 6328
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubation;Difficult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Laryngoscopy time

  Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.

• Percentage of glottic opening (POGO) score

  Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.

• Tube insertion time

  Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.

• Primary intubation attempt success rate

  Measured once after intubation. Up to 120 seconds following the start of intubation attempt.

Study Arms (3)

Macintosh laryngoscopy

ACTIVE COMPARATOR

In this group intubation attempt is carried out with a standard Macintosh (size 3 or 4) direct laryngoscopy blade.

Device: Direct laryngoscopy

KingVision videolaryngoscope

ACTIVE COMPARATOR

In this group intubation attempt is carried out with KingVision videolaryngoscope with a channeled, disposable single-use blade.

Device: KingVision videolaryngoscope

VividTrac videolaryngoscope

ACTIVE COMPARATOR

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

Interventions

Direct laryngoscopy DEVICE

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.

Macintosh laryngoscopy

Vividtrac videolaryngoscope DEVICE

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.

VividTrac videolaryngoscope

KingVision videolaryngoscope DEVICE

During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a KingVision videolaryngoscope.

KingVision videolaryngoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

University of Pécs, Dept. of Anaesthesia and Intensive Care

Pécs, Baranya, 7622, Hungary

RECRUITING

Related Publications (1)

• 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.

  PMID: 28549421 BACKGROUND

Study Officials

• Bálint Nagy, MD PhD

  Department of Anesthesiology and Intensive Therapy, University of Pécs, Hungary

  STUDY CHAIR

• Szilárd Rendeki, MD

  Department of Anesthesiology and Intensive Therapy, University of Pécs, Hungary

  STUDY CHAIR

• Lajos Bogár, MD PhD DSc

  Department of Anesthesiology and Intensive Therapy, University of Pécs, Hungary

  STUDY CHAIR

Central Study Contacts

Gábor Woth, MD PhD

CONTACT

+36703729231; glwoth@gmail.com

Dóra Keresztes, MD

CONTACT

+36303875837; keresztesdora87@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Following informed consent participants are randomised into one of the device groups and general anaesthesia is induced. Primary intubation attempt is carried out with the randomised device. We do not disclose the result of randomisation with our participants prior to anaesthesia induction. Participants are already in surgical anaesthesia with muscle relaxation during the intubation attempt. As providers are the users of the intubation device masking is not possible in this regard. During outcome assessment we plan not to disclose which device was used for a certain group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical resident, PhD

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: September 1, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 1, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)