PediatricPediatricNCT07837882
Two Different Videolaryngoscopes Were Used İn The Pediatric Patient Group
An observational study of Pediatric and Intubation, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
Modern alternatives to traditional laryngoscopes utilize fiber optic or digital technology to project images from the tip of the laryngoscope onto an eyepiece or monitor for improved visualization by the practitioner. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Pediatric, Intubation
- What is being tested?
- In this group, intubation will be performed using a Endolarenx brand videolaryngoscope and In this group, intubation will be performed using a Besdata brand videolaryngoscope
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric participant
Who may be able to join
- ASA I-II
- 10-40 kg
- 2-10 years old
- Elective surgery
- Requirement for intubation under general anesthesia
- Expected normal airway
Who cannot join
- Difficult airway on preoperative assessment
- Need for rapid serial intubation
- History of previous difficult intubation
- Cervical instability
- Upper respiratory tract infection within the last 4 weeks
- Neuromuscular disease
- History of asthma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Samsun University
Samsun, Mağaza Seçiniz, 55090
Hatice Selcuk Kuşderci, 05052159896, drkusderci@hotmail.com
About this study
Official title: Evaluation Of Two Different Videolaryngoscopes İn A Pediatric Patient Group; Prospectus Observational Study
Modern alternatives to traditional laryngoscopes utilize fiber optic or digital technology to project images from the tip of the laryngoscope onto an eyepiece or monitor for improved visualization by the practitioner. Videolaryngoscopes have become an integral part of routine clinical practice and training programs, and a preferred option after failed DL (directional visualization). This study will compare two different videolaryngoscopes in pediatric participants.
Read the detailed description
Based on current literature data, it is suggested that videolaryngoscopy should be considered as the first choice in neonates and infants and that its integration into routine pediatric anesthesia practice may be appropriate. However, it is reported that videolaryngoscopy, compared to direct laryngoscopy, can partially separate the relationship between glottic visualization quality and tracheal tube placement difficulty. Currently, there is no standardized and widely accepted classification system specific to videolaryngoscopy tracheal intubation in pediatric patients. To address this deficiency, the Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification (PeDiAC) score was developed and prospectively defined and validated to determine the difficulty level of pediatric videolaryngoscopy intubation. In this study, the diagnostic performance of the PeDiAC score was evaluated in comparison with the traditionally used Cormack-Lehane classification, and its superiority was investigated. In this planned study, the primary outcome to be evaluated is intubation time, while the secondary outcome is assessed using the PeDiAC score. The aim is to compare the difficulty of intubation between the two devices based on this score. This study aims to determine whether there are differences between the two different videolaryngoscopes in terms of similar clinical outcomes.
- Conditions
- Pediatric, Intubation
- Being tested
- In this group, intubation will be performed using a Endolarenx brand videolaryngoscope, In this group, intubation will be performed using a Besdata brand videolaryngoscope
- Keywords
- Pediatric, videolaryngoscope, PEDİAC Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In this group, intubation will be performed using a Endolarenx brand videolaryngoscopeDevice
In this group, intubation will be performed using a Endolarenx brand videolaryngoscope
In this group, intubation will be performed using a Besdata brand videolaryngoscopeDevice
In this group, intubation will be performed using a Besdata brand videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| group E | In this group, intubation will be performed using an Endolarenx brand videolaryngoscope. Receives: Device: In this group, intubation will be performed using a Endolarenx brand videolaryngoscope | |
| Grup B | In this group, intubation will be performed using a Besdata brand videolaryngoscope. Receives: Device: In this group, intubation will be performed using a Besdata brand videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
The time elapsed from the passage of the laryngoscope blade through the teeth to the detection of end-tidal CO₂.
Measured: 2 minutes after induction
Secondary outcomes (3)
PeDiAC Score
Determining the difficulty level of pediatric videolaryngoscopy intubation.
Measured: 1 hour
Cormack-Lehane glottic view scale
The Cormack-Lehane glottic view classification describes laryngeal visualization during direct laryngoscopy: Grade I indicates a full view of the glottis, Grade II a partial view of the glottis, Grade III visualization of the epiglottis only, and Grade IV visualization of neither the glottis nor the epiglottis.
Measured: 1 hour
Successful intubation attempt
The attempt is considered successful if tracheal intubation is achieved and unsuccessful if intubation fails. Recorded during airway management
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 May 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hatice Selcuk Kuşderci, Study director, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837882
- Sponsor's protocol ID
- GOKAEK 2026/6/11
- Acronym
- Pediatric
- Status last verified
- May 2026
- First submitted
- 1 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Two Different Videolaryngoscopes İn A Pediatric Patient Group; Prospectus Observational Study
- ClinicalTrials.gov ID
- NCT07837882
- Acronym / sponsor ID
- Pediatric / GOKAEK 2026/6/11
- Conditions
- Pediatric, Intubation
- Keywords
- Pediatric, videolaryngoscope, PEDİAC Score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Sep 2026 (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.
Modern alternatives to traditional laryngoscopes utilize fiber optic or digital technology to project images from the tip of the laryngoscope onto an eyepiece or monitor for improved visualization by the practitioner. Videolaryngoscopes have become an integral part of routine clinical practice and training programs, and a preferred option after failed DL (directional visualization). This study will compare two different videolaryngoscopes in pediatric participants.
Detailed description
Based on current literature data, it is suggested that videolaryngoscopy should be considered as the first choice in neonates and infants and that its integration into routine pediatric anesthesia practice may be appropriate. However, it is reported that videolaryngoscopy, compared to direct laryngoscopy, can partially separate the relationship between glottic visualization quality and tracheal tube placement difficulty. Currently, there is no standardized and widely accepted classification system specific to videolaryngoscopy tracheal intubation in pediatric patients. To address this deficiency, the Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification (PeDiAC) score was developed and prospectively defined and validated to determine the difficulty level of pediatric videolaryngoscopy intubation. In this study, the diagnostic performance of the PeDiAC score was evaluated in comparison with the traditionally used Cormack-Lehane classification, and its superiority was investigated. In this planned study, the primary outcome to be evaluated is intubation time, while the secondary outcome is assessed using the PeDiAC score. The aim is to compare the difficulty of intubation between the two devices based on this score. This study aims to determine whether there are differences between the two different videolaryngoscopes in terms of similar clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group E | – | Device: In this group, intubation will be performed using a Endolarenx brand videolaryngoscopeIn this group, intubation will be performed using an Endolarenx brand videolaryngoscope. |
| Grup B | – | Device: In this group, intubation will be performed using a Besdata brand videolaryngoscopeIn this group, intubation will be performed using a Besdata brand videolaryngoscope. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric participant
Key inclusion criteria (6 listed)
- ASA I-II
- 10-40 kg
- 2-10 years old
- Elective surgery
- Requirement for intubation under general anesthesia
Key exclusion criteria (7 listed)
- Difficult airway on preoperative assessment
- Need for rapid serial intubation
- History of previous difficult intubation
- Cervical instability
- Upper respiratory tract infection within the last 4 weeks
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 |
|---|---|---|
| In this group, intubation will be performed using a Endolarenx brand videolaryngoscopeIn this group, intubation will be performed using a Endolarenx brand videolaryngoscope | Device | group E |
| In this group, intubation will be performed using a Besdata brand videolaryngoscopeIn this group, intubation will be performed using a Besdata brand videolaryngoscope | Device | Grup B |
Primary outcome
intubation time
Time frame: 2 minutes after induction
The time elapsed from the passage of the laryngoscope blade through the teeth to the detection of end-tidal CO₂.
3 secondary outcomes
PeDiAC Score
Time frame: 1 hour
Cormack-Lehane glottic view scale
Time frame: 1 hour
Successful intubation attempt
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request
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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.
Hatice Selcuk Kuşderci study director
Samsun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric and Intubation, run by Samsun 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatice Selcuk Kuşderci (+905052159896, drkusderci@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intubation time (time frame: 2 minutes after induction). 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 24 Sep 2026.