HypoxemiaKingVisionNCT02344030
Comparsion of King Vision® Standard Blade and King Vision® Channeled Blade in Patients Scheduled for Tracheal Intubation
A study testing channeled blade and standard blade in people with Hypoxemia, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Comparison of intubation time from the time to fix the Trachealtube to the first end-tidal CO2 ventilation by means of the curve on the ventilator at KV standard blade and KV channeled blade Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia
- What is being tested?
- channeled blade and standard blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Feb 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 Years No concurrent participation in another study
- capacity to consent
- Present written informed consent of the research participant
- Elective surgery under general anesthesia
Who cannot join
- Age <18 years
- Existing pregnancy
- Lack of consent
- inability to consent
- emergency patients
- Emergency situations in the context of a Difficult Airway Management
Show all 9Show fewer
- ASA classification> 3
- situations where the possibility of accumulated gastric contents
- Participation in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
Mainz, Rhineland-Palatinate, D55131
About this study
Official title: Comparative Study of King Vision® Standard Blade and King Vision® Channeled for Tracheal Intubation: a Prospective Randomised Study
Comparison of intubation time from the time to fix the Trachealtube to the first end-tidal CO2 ventilation by means of the curve on the ventilator at KV standard blade and KV channeled blade
Read the detailed description
In the proposed clinical trial the time measured until the first manual ventilation at 44 study participants with elective anesthesia by using the KV standard blade and KV channeled blade. Bedside the time for tracheal intubation, we documented the view on the monitor which is connected to the instrument, the C\& L classification and POGO Scale.
- Conditions
- Hypoxemia
- Being tested
- channeled blade, standard blade
- Keywords
- airway, videolaryngoscope
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
channeled bladeDevice
In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve
standard bladeDevice
In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve
| Study group | Role | What they receive |
|---|---|---|
| standard blade | Experimental | Standard Blade: tracheal intubation with standard blade Receives: Device: channeled blade; Device: standard blade |
| channeled blade | Experimental | Channeled Blade: tracheal intubation with channeled blade Receives: Device: channeled blade; Device: standard blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of different time for tracheal intubation
We want to measure the time for tracheal intubation
Measured: <2min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypoxemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Kriege, MD, Johannes Gutenberg University Mainz
- Investigators
- Marc Kriege, MD, Principal investigator, University JG, Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344030
- Sponsor's protocol ID
- JohannesGUKV
- Acronym
- KingVision
- Status last verified
- Aug 2018
- First submitted
- 13 Jan 2015
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Murphy LD, Kovacs GJ, Reardon PM, Law JA. Comparison of the king vision video laryngoscope with the macintosh laryngoscope. J Emerg Med. 2014 Aug;47(2):239-46. doi: 10.1016/j.jemermed.2014.02.008. Epub 2014 Apr 16.
PubMed 24742495Akihisa Y, Maruyama K, Koyama Y, Yamada R, Ogura A, Andoh T. Comparison of intubation performance between the King Vision and Macintosh laryngoscopes in novice personnel: a randomized, crossover manikin study. J Anesth. 2014 Feb;28(1):51-7. doi: 10.1007/s00540-013-1666-9. Epub 2013 Jun 30.
PubMed 23812581Kriege M, Alflen C, Noppens RR. Using King Vision video laryngoscope with a channeled blade prolongs time for tracheal intubation in different training levels, compared to non-channeled blade. PLoS One. 2017 Aug 31;12(8):e0183382. doi: 10.1371/journal.pone.0183382. eCollection 2017.
PubMed 28859114
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of King Vision® Standard Blade and King Vision® Channeled for Tracheal Intubation: a Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT02344030
- Acronym / sponsor ID
- KingVision / JohannesGUKV
- Conditions
- Hypoxemia
- Keywords
- airway, videolaryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 Jan 2015 (estimated)
- 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 intubation time from the time to fix the Trachealtube to the first end-tidal CO2 ventilation by means of the curve on the ventilator at KV standard blade and KV channeled blade
Detailed description
In the proposed clinical trial the time measured until the first manual ventilation at 44 study participants with elective anesthesia by using the KV standard blade and KV channeled blade. Bedside the time for tracheal intubation, we documented the view on the monitor which is connected to the instrument, the C\& L classification and POGO Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard blade | Experimental | Device: channeled blade, Device: standard bladeStandard Blade: tracheal intubation with standard blade |
| channeled blade | Experimental | Device: channeled blade, Device: standard bladeChanneled Blade: tracheal intubation with channeled blade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 Years No concurrent participation in another study
- capacity to consent
- Present written informed consent of the research participant
- Elective surgery under general anesthesia
Key exclusion criteria (9 listed)
- Age <18 years
- Existing pregnancy
- Lack of consent
- inability to consent
- emergency patients
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 |
|---|---|---|
| channeled bladeIn a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve | Device | channeled blade, standard blade |
| standard bladeIn a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve | Device | channeled blade, standard blade |
Primary outcome
comparison of different time for tracheal intubation
Time frame: <2min
We want to measure the time for tracheal intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Results publication: PubMed 24742495Murphy LD, Kovacs GJ, Reardon PM, Law JA. Comparison of the king vision video laryngoscope with the macintosh laryngoscope. J Emerg Med. 2014 Aug;47(2):239-46. doi: 10.1016/j.jemermed.2014.02.008. Epub 2014 Apr 16.
- Results publication: PubMed 23812581Akihisa Y, Maruyama K, Koyama Y, Yamada R, Ogura A, Andoh T. Comparison of intubation performance between the King Vision and Macintosh laryngoscopes in novice personnel: a randomized, crossover manikin study. J Anesth. 2014 Feb;28(1):51-7. doi: 10.1007/s00540-013-1666-9. Epub 2013 Jun 30.
- Derived from this study: PubMed 28859114Kriege M, Alflen C, Noppens RR. Using King Vision video laryngoscope with a channeled blade prolongs time for tracheal intubation in different training levels, compared to non-channeled blade. PLoS One. 2017 Aug 31;12(8):e0183382. doi: 10.1371/journal.pone.0183382. eCollection 2017.
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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.
Marc Kriege, MD principal investigator
University JG, Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing channeled blade and standard blade in people with Hypoxemia, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 3 Aug 2018. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of different time for tracheal intubation (time frame: <2min). 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 NCT02344030, which also lists 3 linked publications.
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 3 Aug 2018.