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Training Group, SensitivityNCT05946694

Comparison of UESCOPE VL 400, I-VIEW, Airtraq for Tracheal Intubation in Simulated Out-of-Hospital Conditions

An observational study of Training Group, Sensitivity, run by Medical University of Lodz at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In the study, three videolaryngoscopes: UESCOPE VL 400 (Zhejiang UE Medical Corp. Zhejiang, China), I-View™ VL (Intersurgical Ltd, Wokingham, Berkshire, UK), Airtraq sp® (Prodol Meditec S.A, Vizcaya, Spain) were compared with the most widely used, classic Macintosh laryngoscope (HEINE Optotechnik GmbH \& Co. Read more about this study

Who is it for?
Any age
Conditions the study is for
Training Group, Sensitivity
What is being tested?
intubation in manikin
How many people
30 participants
Where
1 sitePoland
Study dates
1 Jan 2022to 1 Feb 2023
Phase
Observational
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
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: intubation effort, intubator comfort, tooth damage and visibility of the glottis according to the Cormack-Lehane scale

Who may be able to join

  • attaneding students

Who cannot join

  • lack of conscent to participate

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Medical University of Lodz, Poland

    Lodz, 90-153

Other trials in Poland

About this study

Official title: Comparison of UESCOPE VL 400, I-VIEW, Airtraq Videolaryngoscopes and Macintosh Laryngoscope for Tracheal Intubation in Simulated Out-of-Hospital Conditions: A Randomized Crossover Manikin Study

In the study, three videolaryngoscopes: UESCOPE VL 400 (Zhejiang UE Medical Corp. Zhejiang, China), I-View™ VL (Intersurgical Ltd, Wokingham, Berkshire, UK), Airtraq sp® (Prodol Meditec S.A, Vizcaya, Spain) were compared with the most widely used, classic Macintosh laryngoscope (HEINE Optotechnik GmbH \& Co. KG, Gilch-ing, Germany) under simulated out-of-hospital conditions by people without clinical experience on a manikin model (Laerdal Airway Management Trainer Stavanger Norway manikin of universal difficulty), while using an endotracheal tube without and with a stylet. Simulated out-of-hospital conditions were created by placing the manikin at floor level. A random selection of 30 students of the third year of Emergency Medicine, full-time first-degree program at the Medical University of Lodz, Poland, were enrolled in the study. The following were assessed: intubation efficiency, time to ventilation (primary endpoints); intubation effort, intubator comfort, tooth damage and visibility of the glottis according to the Cormack-Lehane scale (secondary endpoints).

Read the detailed description

Pre-study preparation All participants attended a 30-minute lecture on laryngoscope construction, principles of usage, anatomical structure of the airways, and intubation techniques. Following the lecture, the instructor demonstrated proper intubation using each of the four laryngoscopes that were being tested. Next, the students participated in a supervised workshop where they had the opportunity to intubate a mannequin placed on an operating table at an optimal height using each of the tested laryngoscopes with and without a stylet. One month later, 30 students participated in the actual study.

Simulation model To create simulated out-of-hospital conditions, a certified airway training manikin (Laerdal Airway Management Trainer Stavanger Norway of universal difficulty) was placed in a neutral position at floor level.

The trial tested three unchanneled videolaryngoscopes: UESCOPE VL 400 (Zhejiang UE Medical Corp. Zhejiang, China), I-View™ VL (Intersurgical Ltd, Wokingham, Berkshire, UK), Airtraq sp ® (Prodol Meditec S.A, Vizcaya, Spain), and a Macintosh laryngoscope (HEINE Optotechnik GmbH \& Co. KG, Gilch-ing, Germany) (see Fig. 1).

Each participant performed eight intubations on the manikin using all four devices. The intubation order was randomized using a blocked randomization strategy generated by the Randomizer Program (randomizer.org). A sealed opaque envelope was used to determine the order in which the laryngoscopes were used, and whether the tube was with or without a stylet.

After each intubation, there was a minimum 10-minute pause before the next one. The subject then proceeded to the next intubation with the randomly selected laryngoscope, with the tube and stylet as determined by the sealed envelope.

All intubations were performed using a polyvinyl chloride cuffed endotracheal tube (Covidien LLC, Hampshire Street, Mansfield, USA; internal diameter 7.0 mm) and an endotracheal stylet (Sumi® from sp. z o.o., 35 Drobiarska Street, 05-070 Sulejówek, Poland), when used. The endotracheal tubes and stylets were coated with a standard lubricant for simulators. All data were pseudonymized for each simulation.

The time was measured by the same investigator (P.R.) using a stopwatch for all TI attempts. The timing measurement started when the participant picked up the laryngoscope and ended when initial ventilation was achieved using a resuscitation bag after the placement and sealing of the endotracheal tube. Successful TI was confirmed by observing the breathing movements of the manikin lungs. An unsuccessful attempt was defined by the absence of respiratory movements of the dummy or an intubation time of more than 60 seconds. This criterion was adopted because the study aimed to assess the suitability of the devices for individuals without clinical experience in intubation. Participants without sufficient skills or a good view of the glottis could prolong intubations without knowing how to solve the problem. In a real clinical scenario, such prolongation of intubation attempts beyond 60 seconds could result in irreversible brain damage in the victim, especially considering the necessary time for the emergency medical team to arrive.

Participants rated the level of effort required to perform TI using the modified Borg scale (0 - no effort, 10 - maximum effort) and graded their comfort during the procedure as "full comfort, satisfactory comfort, moderate comfort, unsatisfactory comfort, and no comfort."

Being tested
intubation in manikin
Keywords
laryngoscopy, endotracheal intubation, manikin study, videolaryngoscopes
Medical subject headings
Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intubation in manikinOther

    Evaluation of 3 videolaryngoscopes under simulated out-of-hospital conditions by people without clinical experience on a manikin model

Study groups in NCT05946694
Study groupRoleWhat they receive
students30 students of the third year of Emergency Medicine, full-time first-degree program at the Medical University of Lodz, Poland, were enrolled in the study.
Receives: Other: intubation in manikin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time to ventilation

    time from grabbing the laryngoscope to confirmed intubation measured in sec

    Measured: during the procedure

  2. intubation efficacy

    endotracheal intubation confirmed by ventilation of manikin's lungs, measured yes/no

    Measured: during the procedure

Secondary outcomes (4)
  1. intubation effort

    how many intubations are required to success, measured in number of attempts

    Measured: during the procedure

  2. intubator comfort,

    operator's experience measured with Borg scale

    Measured: during the procedure

  3. tooth damage

    tooth damage recorded by manikin sensors, measured yes/no

    Measured: during the procedure

  4. visibility of the glottis according to the Cormack-Lehane scale

    visibility of glottis in Cormack-Lehane score assessed by operators, measured using Cormack-Lehane scale

    Measured: during the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2023
  2. Study start1 Jan 2022
  3. Primary completion1 Dec 2022
  4. Study completion1 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Cross-sectional
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05946694
Sponsor's protocol ID
RNN/363/13/KB
Status last verified
Jul 2023
First submitted
16 Jun 2023
Last updated
14 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Training Group, Sensitivity, run by Medical University of Lodz 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 1 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 14 Jul 2023. 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 ventilation (time frame: during the procedure). The study lists 2 primary outcomes in all. 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 14 Jul 2023.

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