Tracheal IntubationNCT04363775
Comparison of VieScope vs. Macintosh Laryngoscope for Intubation in Level Cpersonal Protective Equipment Conditions
A study testing The standard Macintosh laryngoscope and The Vie Scope laryngoscope in people with Tracheal Intubation and Infection, run by Lazarski University at 1 site in Poland.
Trial summary
The current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tracheal Intubation, Infection, Projection
- What is being tested?
- The standard Macintosh laryngoscope and The Vie Scope laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 sitePoland
- Study dates
- 20 Jan 2020to 25 Feb 2020
- 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
- paramedic
- consent voluntary participation in the study
- none experience in Vie Scope
- none experience in intubation with personal protective equipment
Who cannot join
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of VieScope Versus Macintosh Laryngoscope for Emergency Intubation Under Level C Personal Protective Equipment Conditions
The current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. As recommended by the CDC for aerosol-generating procedures (AGP), medical personnel should be equipped with full personal protective equipment (PPE) for AGP. Therefore, it is reasonable to search for the most effective methods of intubation in those conditions.
- Conditions
- Tracheal Intubation, Infection, Projection
- Being tested
- The standard Macintosh laryngoscope, The Vie Scope laryngoscope
- Keywords
- SARS-CoV-2, COVID-19, tracheal intubation, laryngoscope, personal protective equipment
- Medical subject headings
- Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The standard Macintosh laryngoscopeDevice
Also called MAC
intubation with the standard Macintosh laryngoscope and endotracheal tube 7.0 internal diameter with standard tube stylet
The Vie Scope laryngoscopeDevice
Also called VSCOPE
intubation with the Vie Scope laryngoscope with bougie stylet and endotracheal tube 7.0 internal diameter
| Study group | Role | What they receive |
|---|---|---|
| Regurgitation | Experimental | intubation in regurgitation condition Receives: Device: The standard Macintosh laryngoscope; Device: The Vie Scope laryngoscope |
| Tongue edema | Experimental | intubation in Tongue edema condition Receives: Device: The standard Macintosh laryngoscope; Device: The Vie Scope laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to intubation
time from pick up device to the final placement tube in trachea
Measured: 1 day
Secondary outcomes (5)
success of intubation
A failed intubation attempt was defined as an attempt in which the trachea was not intubated, or which required more than 120 seconds to perform
Measured: 1 day
Number of optimalization maneuvers
the number of optimization maneuvers required (re-adjustment of head position, second assistant) to aid endotracheal intubation
Measured: 1 day
Procedure Ease of use
self-reported percentage the vocal cord visualization. A 100% score is a extremely difficult procedure. A Ease of use score of 1% means that procedure is extremely easy
Measured: 1 day
the degree of visibility of the glottis
The POGO score describes how much glottic opening is visible. A POGO score of 100% indicates visualization of the entire glottic opening from the anterior commissure of the vocal cords to the interarytenoid notch. A POGO score of 0% corresponds with no visualization of laryngeal structures.
Measured: 1 day
Cormack - Lehane grade
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start20 Jan 2020
- Primary completion23 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal IntubationStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lazarski University
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University of Medical Sciences, Wroclaw Medical University, Medical University of Bialystok
- Responsible party
- Principal investigator, Łukasz Szarpak, Lazarski University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363775
- Sponsor's protocol ID
- INT_PPE_2020_1
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we will decided after finishing manuscript
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of VieScope Versus Macintosh Laryngoscope for Emergency Intubation Under Level C Personal Protective Equipment Conditions
- ClinicalTrials.gov ID
- NCT04363775
- Acronym / sponsor ID
- INT_PPE_2020_1
- Conditions
- Tracheal Intubation, Infection, Projection
- Keywords
- SARS-CoV-2, COVID-19, tracheal intubation, laryngoscope, personal protective equipment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Lazarski UniversityUniversity, hospital or other
- Collaborators
- Poznan University of Medical Sciences, Wroclaw Medical University, Medical University of Bialystok
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 23 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 27 Apr 2020 (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.
The current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. As recommended by the CDC for aerosol-generating procedures (AGP), medical personnel should be equipped with full personal protective equipment (PPE) for AGP. Therefore, it is reasonable to search for the most effective methods of intubation in those conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regurgitation | Experimental | Device: The standard Macintosh laryngoscope, Device: The Vie Scope laryngoscopeintubation in regurgitation condition |
| Tongue edema | Experimental | Device: The standard Macintosh laryngoscope, Device: The Vie Scope laryngoscopeintubation in Tongue edema condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- paramedic
- consent voluntary participation in the study
- none experience in Vie Scope
- none experience in intubation with personal protective equipment
Key exclusion criteria (1 listed)
- refusal to participate in the study
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 |
|---|---|---|
| The standard Macintosh laryngoscopeAlso: MACintubation with the standard Macintosh laryngoscope and endotracheal tube 7.0 internal diameter with standard tube stylet | Device | Regurgitation, Tongue edema |
| The Vie Scope laryngoscopeAlso: VSCOPEintubation with the Vie Scope laryngoscope with bougie stylet and endotracheal tube 7.0 internal diameter | Device | Regurgitation, Tongue edema |
Primary outcome
time to intubation
Time frame: 1 day
time from pick up device to the final placement tube in trachea
5 secondary outcomes
success of intubation
Time frame: 1 day
Number of optimalization maneuvers
Time frame: 1 day
Procedure Ease of use
Time frame: 1 day
the degree of visibility of the glottis
Time frame: 1 day
Cormack - Lehane grade
Time frame: 1 day
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 28 Apr 2020.
- Individual participant dataSharing planned: Undecided. we will decided after finishing manuscript
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The standard Macintosh laryngoscope and The Vie Scope laryngoscope in people with Tracheal Intubation and Infection, run by Lazarski University at 1 site in Poland.
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 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: finished, as of the sponsor's last update on 28 Apr 2020. 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 Poland. 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?
time to intubation (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2020.