VideolaryngoscopyVIDEOPEDNCT07141485
Comparison of PeDiAC and the Intubation Difficulty Scale in Pediatric Patients Intubated With Videolaryngoscopy
An observational study of Videolaryngoscopy and Difficult Airway, Videolaryngoscopes, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to compare the effectiveness of the Paediatric Videolaryngoscopic Intubation and Difficult Airway Classification (PeDiAC) and the Intubation Difficulty Scale (IDS) in evaluating difficult tracheal intubation in pediatric patients aged 0 to 5 years. Read more about this study
- Who is it for?
- Ages 0 to 5 years
- Conditions the study is for
- Videolaryngoscopy, Difficult Airway, Videolaryngoscopes, Airway Management Assessment
- How many people
- 430 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2025to 30 Jan 2026
- Phase
- Observational
- 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 0 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: This study will enroll pediatric patients aged 0 to 5 years who are undergoing general anesthesia for elective and emergent surgical procedures requiring tracheal intubation. Patients will be intubated using a videolaryngoscope. Subjects with difficult airway history, emergency surgery, or airway pathology will be excluded. The study aims to compare two scoring systems evaluating intubation difficulty in this age group.
Who may be able to join
- Pediatric patients between 0 and 5 years of age
- Undergoing general anesthesia for any type of surgical procedure
- ASA physical status classification I to IV
- Written informed consent obtained from parents or legal guardians
Who cannot join
- Patients undergoing awake fiberoptic intubation
- History of tracheal resection or reconstruction surgery
- Refusal to participate or absence of informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital, Department Of Anesthesiology and Reanimation
Ankara, Turkiye
About this study
Official title: Comparison of the PeDiAC Score and Intubation Difficulty Scale in Pediatric Patients Aged 0-5 Years Undergoing Tracheal Intubation With Videolaryngoscopy
This prospective observational study aims to compare the effectiveness of the Paediatric Videolaryngoscopic Intubation and Difficult Airway Classification (PeDiAC) and the Intubation Difficulty Scale (IDS) in evaluating difficult tracheal intubation in pediatric patients aged 0 to 5 years. Patients undergoing general anesthesia with videolaryngoscopic intubation will be assessed using both scoring systems. The study seeks to determine which system more accurately reflects the difficulty of intubation and serves as a better guide for future anesthetic management, ultimately contributing to improved patient safety.
Read the detailed description
This prospective observational study aims to compare the effectiveness of two scoring systems-Paediatric Videolaryngoscopic Intubation and Difficult Airway Classification (PeDiAC) and the Intubation Difficulty Scale (IDS)-in assessing the difficulty of tracheal intubation in pediatric patients aged 0 to 5 years. Pediatric patients undergoing elective or emergency surgery under general anesthesia will be included in the study. All intubations will be performed using a C-MAC videolaryngoscope.
Demographic data such as age, sex, weight, height, ASA physical status, and comorbidities will be recorded. Intraoperative monitoring parameters including peripheral oxygen saturation (SpO₂) and heart rate will also be documented. During intubation, the glottic view will be graded according to the Modified Cormack-Lehane classification.
Additional variables-including the time required to achieve optimal glottic visualization, total intubation time (from insertion of the device to cuff inflation), number of intubation attempts, and any complications (e.g., desaturation, mucosal bleeding)-will be noted.
Following intubation, both the intubating anesthesiologist and an independent observer will assign a subjective difficulty score using a visual analog scale ranging from 0 (extremely easy) to 10 (impossible). Subsequently, PeDiAC and IDS scores will be calculated for each case.
The primary objective is to determine which of the two scoring systems more accurately reflects the actual difficulty of tracheal intubation in this age group and to identify the one that may better guide future airway management strategies-ultimately aiming to improve safety and clinical outcomes in pediatric anesthesia.
- Conditions
- Videolaryngoscopy, Difficult Airway, Videolaryngoscopes, Airway Management Assessment, Pediatric Anesthesia
- Keywords
- Pediatric intubation, Difficult airway, PeDiAC, Intubation Difficulty Scale (IDS), Videolaryngoscopy, Modified Cormack-Lehane classification, Pediatric anesthesia, Tracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Patients Undergoing Videolaryngoscopic Intubation | This group includes pediatric patients aged 0-5 years undergoing elective or emergency surgery under general anesthesia with videolaryngoscopic intubation. All patients will be evaluated for intubation difficulty using both the PeDiAC and the Intubation Difficulty Scale (IDS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of PeDiAC Score and IDS Score for Predicting Difficult Intubation in Children Aged 0-5 Years
This outcome measure evaluates the effectiveness of two scoring systems-PeDiAC and Intubation Difficulty Scale (IDS)-in reflecting the difficulty of tracheal intubation in pediatric patients aged 0 to 5 years. Both scores will be calculated for each patient immediately after intubation. The correlation between each score and the actual intubation experience will be statistically analyzed to determine which scoring system better predicts intubation difficulty.
Measured: Immediately after tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start28 Aug 2025
- Primary completion20 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VideolaryngoscopyStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141485
- Sponsor's protocol ID
- PEDIAC-VL-2025-GID
- Acronym
- VIDEOPED
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the PeDiAC Score and Intubation Difficulty Scale in Pediatric Patients Aged 0-5 Years Undergoing Tracheal Intubation With Videolaryngoscopy
- ClinicalTrials.gov ID
- NCT07141485
- Acronym / sponsor ID
- VIDEOPED / PEDIAC-VL-2025-GID
- Conditions
- Videolaryngoscopy, Difficult Airway, Videolaryngoscopes, Airway Management Assessment, Pediatric Anesthesia
- Keywords
- Pediatric intubation, Difficult airway, PeDiAC, Intubation Difficulty Scale (IDS), Videolaryngoscopy, Modified Cormack-Lehane classification, Pediatric anesthesia, Tracheal intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 26 Aug 2025 (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.
This prospective observational study aims to compare the effectiveness of the Paediatric Videolaryngoscopic Intubation and Difficult Airway Classification (PeDiAC) and the Intubation Difficulty Scale (IDS) in evaluating difficult tracheal intubation in pediatric patients aged 0 to 5 years. Patients undergoing general anesthesia with videolaryngoscopic intubation will be assessed using both scoring systems. The study seeks to determine which system more accurately reflects the difficulty of intubation and serves as a better guide for future anesthetic management, ultimately contributing to improved patient safety.
Detailed description
This prospective observational study aims to compare the effectiveness of two scoring systems-Paediatric Videolaryngoscopic Intubation and Difficult Airway Classification (PeDiAC) and the Intubation Difficulty Scale (IDS)-in assessing the difficulty of tracheal intubation in pediatric patients aged 0 to 5 years. Pediatric patients undergoing elective or emergency surgery under general anesthesia will be included in the study. All intubations will be performed using a C-MAC videolaryngoscope.
Demographic data such as age, sex, weight, height, ASA physical status, and comorbidities will be recorded. Intraoperative monitoring parameters including peripheral oxygen saturation (SpO₂) and heart rate will also be documented. During intubation, the glottic view will be graded according to the Modified Cormack-Lehane classification.
Additional variables-including the time required to achieve optimal glottic visualization, total intubation time (from insertion of the device to cuff inflation), number of intubation attempts, and any complications (e.g., desaturation, mucosal bleeding)-will be noted.
Following intubation, both the intubating anesthesiologist and an independent observer will assign a subjective difficulty score using a visual analog scale ranging from 0 (extremely easy) to 10 (impossible). Subsequently, PeDiAC and IDS scores will be calculated for each case.
The primary objective is to determine which of the two scoring systems more accurately reflects the actual difficulty of tracheal intubation in this age group and to identify the one that may better guide future airway management strategies-ultimately aiming to improve safety and clinical outcomes in pediatric anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Patients Undergoing Videolaryngoscopic Intubation | – | –This group includes pediatric patients aged 0-5 years undergoing elective or emergency surgery under general anesthesia with videolaryngoscopic intubation. All patients will be evaluated for intubation difficulty using both the PeDiAC and the Intubation Difficulty Scale (IDS). |
Who may qualify
- Ages
- 0 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will enroll pediatric patients aged 0 to 5 years who are undergoing general anesthesia for elective and emergent surgical procedures requiring tracheal intubation. Patients will be intubated using a videolaryngoscope. Subjects with difficult airway history, emergency surgery, or airway pathology will be excluded. The study aims to compare two scoring systems evaluating intubation difficulty in this age group.
Key inclusion criteria (4 listed)
- Pediatric patients between 0 and 5 years of age
- Undergoing general anesthesia for any type of surgical procedure
- ASA physical status classification I to IV
- Written informed consent obtained from parents or legal guardians
Key exclusion criteria (3 listed)
- Patients undergoing awake fiberoptic intubation
- History of tracheal resection or reconstruction surgery
- Refusal to participate or absence of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of PeDiAC Score and IDS Score for Predicting Difficult Intubation in Children Aged 0-5 Years
Time frame: Immediately after tracheal intubation
This outcome measure evaluates the effectiveness of two scoring systems-PeDiAC and Intubation Difficulty Scale (IDS)-in reflecting the difficulty of tracheal intubation in pediatric patients aged 0 to 5 years. Both scores will be calculated for each patient immediately after intubation. The correlation between each score and the actual intubation experience will be statistically analyzed to determine which scoring system better predicts intubation difficulty.
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 18 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Videolaryngoscopy and Difficult Airway, Videolaryngoscopes, run by Ankara City Hospital Bilkent 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 4 inclusion and 3 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 18 Mar 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?
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?
Comparison of PeDiAC Score and IDS Score for Predicting Difficult Intubation in Children Aged 0-5 Years (time frame: Immediately after tracheal intubation). 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 18 Mar 2026.