NCT05946694

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

June 16, 2023

Last Update Submit

July 13, 2023

Conditions

Keywords

laryngoscopyendotracheal intubationmanikin studyvideolaryngoscopes

Outcome Measures

Primary Outcomes (2)

  • time to ventilation

    time from grabbing the laryngoscope to confirmed intubation measured in sec

    during the procedure

  • intubation efficacy

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

    during the procedure

Secondary Outcomes (4)

  • intubation effort

    during the procedure

  • intubator comfort,

    during the procedure

  • tooth damage

    during the procedure

  • visibility of the glottis according to the Cormack-Lehane scale

    during the procedure

Study Arms (1)

students

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.

Other: intubation in manikin

Interventions

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

students

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • attaneding students

You may not qualify if:

  • lack of conscent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Lodz, Poland

Lodz, 90-153, Poland

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

IntubationManikins

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative TechniquesModels, AnatomicModels, StructuralAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Tomasz Gaszynski, Prof

    Medical University of Lodz, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr hab.

Study Record Dates

First Submitted

June 16, 2023

First Posted

July 14, 2023

Study Start

January 1, 2022

Primary Completion

December 1, 2022

Study Completion

February 1, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Locations