Intubation;DifficultNCT03624439
Duble Lumen Intubation
A study testing Standard double-lumen tube and Double-Lumen Tube Vivasight-DL in people with Intubation;Difficult and Intubation; Difficult or Failed, run by Lazarski University at 1 site in Poland.
Trial summary
Intrabronal intubation is one of the basic methods of airway protection during cardiac surgery. The use of double-lumen tubes in the implementation of a standard method based on macintosh laryngoscope may cause the prolongation of the procedure especially in the case of difficult airways. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intubation;Difficult, Intubation; Difficult or Failed, Difficult Airway
- What is being tested?
- Standard double-lumen tube and Double-Lumen Tube Vivasight-DL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 sitePoland
- Study dates
- 7 Aug 2018to 30 Jun 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- anesthesiologist or a person in the course of specialization
- consent voluntary participation in the study
Who cannot join
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Poland1 site
Faculty of Medicine, Lazarski University
Warsaw, Masovian Voivodeship, 02-662
About this study
Official title: Evaluation of the Double-Lumen Tube Vivasight-DL vs. Standard Duble-lumen Tube in Normal and Difficult Airway Scenarios: A Prospective, Randomized, Crossover, Simulation Trial
Intrabronal intubation is one of the basic methods of airway protection during cardiac surgery. The use of double-lumen tubes in the implementation of a standard method based on macintosh laryngoscope may cause the prolongation of the procedure especially in the case of difficult airways. The aim of the study was to match the effectiveness of endotracheal intubation using a standard Macontosh laryngskop and a normal double-lumen tube versus the ETView DL tube.
- Being tested
- Standard double-lumen tube, Double-Lumen Tube Vivasight-DL
- Keywords
- double-lumen tube, ETView, medical simulation, anesthesiologist, difficult airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard double-lumen tubeDevice
intubation using standard double-lumen tube with Macintosh laryngoscope
Double-Lumen Tube Vivasight-DLDevice
intubation using Double-Lumen Video Tube Vivasight-DL with Macintosh laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Normal airway | Experimental | normal airway. the language has not been inflated. the instructor assessed the difficulty of intubation based on the Cormack - Lehane scale to the first degree Receives: Device: Standard double-lumen tube; Device: Double-Lumen Tube Vivasight-DL |
| Difficult airway | Experimental | dofficult airway. Difficult airways were obtained by means of language inflation using a simulator control panel, so as to obtain the degree of intubation difficulty assessed by an independent anesthesiologist to the third degree according to the Cormack-Lehane scale Receives: Device: Standard double-lumen tube; Device: Double-Lumen Tube Vivasight-DL |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
from taking of the intubation device to successful intubation
Measured: 1 day
Secondary outcomes (6)
time to visualize the glottis
time defined as the time from taking laryngoscope in hand until you obtain visualize the glottis
Measured: 1 day
success of the first intubation trial
effectiveness of the first attempt of intubation by participants using four intubation devices
Measured: 1 day
overall success rate
effectiveness measured during a maximum of three intubation attempts, confirmed by a single lung ventilation test
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
ease of use
To access subjective opinions about the difficulty of the each intubation method, participants were asked to give a rating on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 100 (extremely difficult).
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 posted10 Aug 2018
- Study start7 Aug 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lazarski University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Szarpak, Lazarski University
- Investigators
- Lukasz Szarpak, PhD, Principal investigator, Lazarski UniversityJacek Smereka, Phd, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624439
- Sponsor's protocol ID
- ETI_2018_DL1
- Status last verified
- Jul 2019
- First submitted
- 7 Aug 2018
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used and/or analyzed during the current study available from the corresponding author on request.
Publications
Bialka S, Copik M, Rybczyk K, Owczarek A, Jedrusik E, Czyzewski D, Filipowski M, Rivas E, Ruetzler K, Szarpak L, Misiolek H. Assessment of changes of regional ventilation distribution in the lung tissue depending on the driving pressure applied during high frequency jet ventilation. BMC Anesthesiol. 2018 Jul 31;18(1):101. doi: 10.1186/s12871-018-0552-2.
PubMed 30064377Szarpak L, Kurowski A, Zasko P, Karczewska K, Czyzewski L, Bogdanski L, Adamczyk P, Truszewski Z. Double-lumen tube tracheal intubation in a manikin model using the VivaSight Double Lumen: a randomized controlled comparison with the Macintosh laryngoscope. Am J Emerg Med. 2016 Jan;34(1):103-4. doi: 10.1016/j.ajem.2015.10.018. Epub 2015 Oct 23. No abstract available.
PubMed 26527175
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Double-Lumen Tube Vivasight-DL vs. Standard Duble-lumen Tube in Normal and Difficult Airway Scenarios: A Prospective, Randomized, Crossover, Simulation Trial
- ClinicalTrials.gov ID
- NCT03624439
- Acronym / sponsor ID
- ETI_2018_DL1
- Keywords
- double-lumen tube, ETView, medical simulation, anesthesiologist, difficult airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Lazarski UniversityUniversity, hospital or other
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 10 Aug 2018 (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.
Intrabronal intubation is one of the basic methods of airway protection during cardiac surgery. The use of double-lumen tubes in the implementation of a standard method based on macintosh laryngoscope may cause the prolongation of the procedure especially in the case of difficult airways. The aim of the study was to match the effectiveness of endotracheal intubation using a standard Macontosh laryngskop and a normal double-lumen tube versus the ETView DL tube.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal airway | Experimental | Device: Standard double-lumen tube, Device: Double-Lumen Tube Vivasight-DLnormal airway. the language has not been inflated. the instructor assessed the difficulty of intubation based on the Cormack - Lehane scale to the first degree |
| Difficult airway | Experimental | Device: Standard double-lumen tube, Device: Double-Lumen Tube Vivasight-DLdofficult airway. Difficult airways were obtained by means of language inflation using a simulator control panel, so as to obtain the degree of intubation difficulty assessed by an independent anesthesiologist to the third degree according to the Cormack-Lehane scale |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- anesthesiologist or a person in the course of specialization
- consent voluntary participation in the study
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 |
|---|---|---|
| Standard double-lumen tubeintubation using standard double-lumen tube with Macintosh laryngoscope | Device | Difficult airway, Normal airway |
| Double-Lumen Tube Vivasight-DLintubation using Double-Lumen Video Tube Vivasight-DL with Macintosh laryngoscope | Device | Difficult airway, Normal airway |
Primary outcome
intubation time
Time frame: 1 day
from taking of the intubation device to successful intubation
6 secondary outcomes
time to visualize the glottis
Time frame: 1 day
success of the first intubation trial
Time frame: 1 day
overall success rate
Time frame: 1 day
the degree of visibility of the glottis
Time frame: 1 day
Cormack - Lehane grade
Time frame: 1 day
ease of use
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 31 Jul 2019.
- Background: PubMed 30064377Bialka S, Copik M, Rybczyk K, Owczarek A, Jedrusik E, Czyzewski D, Filipowski M, Rivas E, Ruetzler K, Szarpak L, Misiolek H. Assessment of changes of regional ventilation distribution in the lung tissue depending on the driving pressure applied during high frequency jet ventilation. BMC Anesthesiol. 2018 Jul 31;18(1):101. doi: 10.1186/s12871-018-0552-2.
- Background: PubMed 26527175Szarpak L, Kurowski A, Zasko P, Karczewska K, Czyzewski L, Bogdanski L, Adamczyk P, Truszewski Z. Double-lumen tube tracheal intubation in a manikin model using the VivaSight Double Lumen: a randomized controlled comparison with the Macintosh laryngoscope. Am J Emerg Med. 2016 Jan;34(1):103-4. doi: 10.1016/j.ajem.2015.10.018. Epub 2015 Oct 23. No abstract available.
- Individual participant dataSharing planned: Undecided. The datasets used and/or analyzed during the current study available from the corresponding author on request.
Related trials for Intubation;Difficult
Not yet recruitingObservational study
A Novel Score for Procedural Difficulty During Videolaryngoscopic Intubation
Intubation, Intratracheal, Airway Management
RecruitingObservational study
Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation
Awake Fiberoptic Intubation, Difficult Airway
Not yet recruitingObservational study
Modified El-Ganzouri Risk Index for Predicting Difficult Intubation in Obese Patients
Difficult Intubation, Obesity
Enrolling by invitationObservational study
Difficult Airway Management in Oncology: An International Delphi Consensus Study (DAMO)
Neoplasms, Airway Obstruction Upper
Not yet recruitingObservational study
Correlation Between Bedside Anatomical Indicators and Lifting Force and Glottic Exposure Under Different Video Laryngoscopy Techniques
Difficult Airway, Intubation, Intratracheal
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.
Lukasz Szarpak, PhD principal investigator
Lazarski University
Jacek Smereka, Phd principal investigator
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard double-lumen tube and Double-Lumen Tube Vivasight-DL in people with Intubation;Difficult and Intubation; Difficult or Failed, 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 2 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 31 Jul 2019. 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?
intubation time (time frame: 1 day). 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 NCT03624439, which also lists 2 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 31 Jul 2019.