Intubation;DifficultNCT03271008
Comparison of the Vividtrac™ and Other Videolaryngoscopes in Clinical Practice
A study testing Direct laryngoscopy, Vividtrac videolaryngoscope and KingVision videolaryngoscope in people with Intubation;Difficult, run by University of Pecs at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- Direct laryngoscopy, Vividtrac videolaryngoscope and KingVision videolaryngoscope
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jan 2017to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
University of Pécs, Dept. of Anaesthesia and Intensive Care
Pécs, Baranya, 7622
Dóra Keresztes, MD
Gábor Woth, MD PhD
About this study
Official title: 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.
- Conditions
- Intubation;Difficult
- Being tested
- Direct laryngoscopy, Vividtrac videolaryngoscope, KingVision videolaryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct laryngoscopyDevice
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.
Vividtrac videolaryngoscopeDevice
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.
KingVision videolaryngoscopeDevice
During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a KingVision videolaryngoscope.
| Study group | Role | What they receive |
|---|---|---|
| Macintosh laryngoscopy | Active comparator | In this group intubation attempt is carried out with a standard Macintosh (size 3 or 4) direct laryngoscopy blade. Receives: 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. Receives: 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. Receives: Device: Vividtrac videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
Secondary outcomes (4)
Laryngoscopy time
Time necessary to achieve best visualisation of the glottic opening.
Measured: 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.
Measured: 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.
Measured: 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: Measured once after intubation. Up to 120 seconds following the start of intubation attempt.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Jan 2017
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation;DifficultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gábor László Woth, University of Pecs
- Investigators
- Bálint Nagy, MD PhD, Study chair, Department of Anesthesiology and Intensive Therapy, University of Pécs, HungarySzilárd Rendeki, MD, Study chair, Department of Anesthesiology and Intensive Therapy, University of Pécs, HungaryLajos Bogár, MD PhD DSc, Study chair, Department of Anesthesiology and Intensive Therapy, University of Pécs, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271008
- Sponsor's protocol ID
- 6328
- Status last verified
- Aug 2017
- First submitted
- 11 May 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28549421
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Necessary Time for Successful Intubation With the Vividtrac™ and KingVision™ Videolaryngoscopes and Macintosh Blade Direct Laryngoscopy in Clinical Practice
- ClinicalTrials.gov ID
- NCT03271008
- Acronym / sponsor ID
- 6328
- Conditions
- Intubation;Difficult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Macintosh laryngoscopy | Active comparator | Device: Direct laryngoscopyIn this group intubation attempt is carried out with a standard Macintosh (size 3 or 4) direct laryngoscopy blade. |
| KingVision videolaryngoscope | Active comparator | Device: KingVision videolaryngoscopeIn this group intubation attempt is carried out with KingVision videolaryngoscope with a channeled, disposable single-use blade. |
| VividTrac videolaryngoscope | Active comparator | Device: Vividtrac videolaryngoscopeIn this group intubation attempt is carried out with VividTrac Adult model using a smartphone or laptop running the VividVision proprietary software. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct laryngoscopyDuring 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. | Device | Macintosh laryngoscopy |
| Vividtrac videolaryngoscopeDuring 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. | Device | VividTrac videolaryngoscope |
| KingVision videolaryngoscopeDuring the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a KingVision videolaryngoscope. | Device | KingVision videolaryngoscope |
Primary outcome
Intubation time
Time frame: Measured once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
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).
4 secondary outcomes
Laryngoscopy time
Time frame: Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
Percentage of glottic opening (POGO) score
Time frame: Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
Tube insertion time
Time frame: Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
Primary intubation attempt success rate
Time frame: Measured once after intubation. Up to 120 seconds following the start of intubation attempt.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Background: PubMed 28549421Rendeki 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bálint Nagy, MD PhD study chair
Department of Anesthesiology and Intensive Therapy, University of Pécs, Hungary
Szilárd Rendeki, MD study chair
Department of Anesthesiology and Intensive Therapy, University of Pécs, Hungary
Lajos Bogár, MD PhD DSc study chair
Department of Anesthesiology and Intensive Therapy, University of Pécs, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct laryngoscopy, Vividtrac videolaryngoscope and KingVision videolaryngoscope in people with Intubation;Difficult, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gábor Woth, MD PhD (+36703729231, glwoth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation time (time frame: Measured once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03271008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.