TelemedicineNCT06497725
Teleguidance-facilitated Airway Management
A study testing Teleguidance-facilitated Airway Management in people with Telemedicine and Intubation; Difficult or Failed, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Telemedicine, Intubation; Difficult or Failed, Emergencies
- What is being tested?
- Teleguidance-facilitated Airway Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 Aug 2024
- 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
- All paramedic students who completed their airway management training
Who cannot join
- The trainees who did not consent to participate
- The trainees who did not complete the VL training
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University Medical Faculty Emergency Medicine Department
Kocaeli, 41730
About this study
Official title: 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.
- Conditions
- Telemedicine, Intubation; Difficult or Failed, Emergencies
- Being tested
- Teleguidance-facilitated Airway Management
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teleguidance-facilitated Airway ManagementDevice
tele-guidence will be provided by an experienced airway expert
| Study group | Role | What they receive |
|---|---|---|
| Teleguidance-facilitated Airway Management | Experimental | The airway expert able to remotely access to videolaryngoscopy monitor will provide verbal feedback during the endotracheal intubation. Receives: Device: Teleguidance-facilitated Airway Management |
| Standard Airway Management | No intervention | Operator will use standard videolaryngoscopy without expert feedback during the endotracheal intubation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at the 60-second mark.
Secondary outcomes (3)
Intubation duration (seconds)
Duration between the passage of the endotracheal tube through the lips and its pass between the vocal cords
Measured: procedure (Measured at the confirmation of the tube passed between vocal cords.)
Operator confidence assessed by Likert Scale.
Self-evaluation of procedure confidence using 7-point Likert Scale
Measured: At the end of the procedure
Feasibility of intubation assessed by Likert Scale.
Self-evaluation of methods feasibility using 7-point Likert Scale
Measured: At the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 May 2024
- Primary completion1 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Ulas Ozturan, Kocaeli University
- Investigators
- Ibrahim Ozturan, Study chair, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497725
- Sponsor's protocol ID
- GOKAEK-2024/07.13
- Status last verified
- Aug 2024
- First submitted
- 28 Jun 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Teleguidance-facilitated Airway Management in Prehospital Emergency Medical Services: A Randomized Controlled Simulation Study
- ClinicalTrials.gov ID
- NCT06497725
- Acronym / sponsor ID
- GOKAEK-2024/07.13
- Conditions
- Telemedicine, Intubation; Difficult or Failed, Emergencies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 12 Jul 2024 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teleguidance-facilitated Airway Management | Experimental | Device: Teleguidance-facilitated Airway ManagementThe airway expert able to remotely access to videolaryngoscopy monitor will provide verbal feedback during the endotracheal intubation. |
| Standard Airway Management | No intervention | –Operator will use standard videolaryngoscopy without expert feedback during the endotracheal intubation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All paramedic students who completed their airway management training
Key exclusion criteria (2 listed)
- The trainees who did not consent to participate
- The trainees who did not complete the VL training
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 |
|---|---|---|
| Teleguidance-facilitated Airway Managementtele-guidence will be provided by an experienced airway expert | Device | Teleguidance-facilitated Airway Management |
Primary outcome
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.
3 secondary outcomes
Intubation duration (seconds)
Time frame: 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
Feasibility of intubation assessed by Likert Scale.
Time frame: At the end of the procedure
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 14 Aug 2024.
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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.
Ibrahim Ozturan study chair
Kocaeli 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 Teleguidance-facilitated Airway Management in people with Telemedicine and Intubation; Difficult or Failed, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 2 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 Aug 2024. 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 Turkey (Türkiye). 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?
Rate of first attempt success (n,%) (time frame: Measured at the 60-second mark.). 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 Aug 2024.