Teleguidance-facilitated Airway Management

August 13, 2024 updated by: Ibrahim Ulas Ozturan, Kocaeli University

Remote Teleguidance-facilitated Airway Management in Prehospital Emergency Medical Services: A Randomized Controlled Simulation Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41730
        • Kocaeli University Medical Faculty Emergency Medicine Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All paramedic students who completed their airway management training

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Teleguidance-facilitated Airway Management
The airway expert able to remotely access to videolaryngoscopy monitor will provide verbal feedback during the endotracheal intubation.
Device: Teleguidance-facilitated Airway Management
tele-guidence will be provided by an experienced airway expert
No Intervention: Standard Airway Management
Operator will use standard videolaryngoscopy without expert feedback during the endotracheal intubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of first attempt success (n,%)
Time Frame: Measured at the 60-second mark.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation duration (seconds)
Time Frame: procedure (Measured at the confirmation of the tube passed between vocal cords.)
Duration between the passage of the endotracheal tube through the lips and its pass between the vocal cords
procedure (Measured at the confirmation of the tube passed between vocal cords.)
Operator confidence assessed by Likert Scale.
Time Frame: At the end of the procedure
Self-evaluation of procedure confidence using 7-point Likert Scale
At the end of the procedure
Feasibility of intubation assessed by Likert Scale.
Time Frame: At the end of the procedure
Self-evaluation of methods feasibility using 7-point Likert Scale
At the end of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Investigators

  • Study Chair: Ibrahim Ozturan, Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

June 28, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOKAEK-2024/07.13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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