NCT06497725

Brief Summary

The advent of telemedicine has introduced teleguidance as a promising support to enhance endotracheal intubation skills among inexperienced operators. Several studies showed the effectiveness of supervisor assisted ETI using the various VL devices and commercial videoconferencing softwares. However, recent developments in VL technologies introduced the VL integrated videoconferencing features for this purpose. Scoper VL device (Technomedicare Inc, Turkiye) developed a real-time teleconsultation feature for difficult airway scenarios to be assisted by experts during the procedure. However, the literature is very limited about the effectiveness and feasibility of teleguidance-facilitated airway management. This high-fidelity simulation study aims to assess impact of teleguidance-facilitated airway management on the success of ETI performed by inexperienced operators in a mobile ambulance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2024

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

June 28, 2024

Last Update Submit

August 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of first attempt success (n,%)

    Visualization of the endotracheal tube passing between the vocal cords within the first 60 seconds of the procedure.

    Measured at the 60-second mark.

Secondary Outcomes (3)

  • Intubation duration (seconds)

    procedure (Measured at the confirmation of the tube passed between vocal cords.)

  • Operator confidence assessed by Likert Scale.

    At the end of the procedure

  • Feasibility of intubation assessed by Likert Scale.

    At the end of the procedure

Study Arms (2)

Teleguidance-facilitated Airway Management

EXPERIMENTAL

The airway expert able to remotely access to videolaryngoscopy monitor will provide verbal feedback during the endotracheal intubation.

Device: Teleguidance-facilitated Airway Management

Standard Airway Management

NO INTERVENTION

Operator will use standard videolaryngoscopy without expert feedback during the endotracheal intubation.

Interventions

tele-guidence will be provided by an experienced airway expert

Teleguidance-facilitated Airway Management

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All paramedic students who completed their airway management training

You may not qualify if:

  • The trainees who did not consent to participate
  • The trainees who did not complete the VL training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Medical Faculty Emergency Medicine Department

Kocaeli, 41730, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ibrahim Ozturan

    Kocaeli University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 28, 2024

First Posted

July 12, 2024

Study Start

May 1, 2024

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

August 14, 2024

Record last verified: 2024-08

Locations