Comparison of the Vividtrac™ and Other Videolaryngoscopes in Clinical Practice

NCT ID: NCT03271008

Last Updated: 2017-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Intubation;Difficult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Macintosh laryngoscopy

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

Group Type ACTIVE_COMPARATOR

Direct laryngoscopy

Intervention Type 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.

KingVision videolaryngoscope

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

Group Type ACTIVE_COMPARATOR

KingVision videolaryngoscope

Intervention Type DEVICE

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

VividTrac videolaryngoscope

In this group intubation attempt is carried out with VividTrac Adult model using a smartphone or laptop running the VividVision proprietary software.

Group Type ACTIVE_COMPARATOR

Vividtrac videolaryngoscope

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

KingVision videolaryngoscope

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

Intervention Type DEVICE

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pecs

OTHER

Sponsor Role lead

Responsible Party

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Gábor László Woth

clinical resident, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bálint Nagy, MD PhD

Role: STUDY_CHAIR

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

Szilárd Rendeki, MD

Role: STUDY_CHAIR

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

Lajos Bogár, MD PhD DSc

Role: STUDY_CHAIR

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

Locations

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University of Pécs, Dept. of Anaesthesia and Intensive Care

Pécs, Baranya, Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Gábor Woth, MD PhD

Role: CONTACT

+36703729231

Dóra Keresztes, MD

Role: CONTACT

+36303875837

References

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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.

Reference Type BACKGROUND
PMID: 28549421 (View on PubMed)

Other Identifiers

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6328

Identifier Type: -

Identifier Source: org_study_id

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