Pediatric Surgical Procedures Requiring Endotracheal Intubation Under General AnesthesiaNCT06937840
Comparison of Optimal Endotracheal Tube Depth Using Four Different Formulas in Children Aged 1-4 Years and Verification With Fiberoptic Bronchoscopy
An observational study of Pediatric Surgical Procedures Requiring Endotracheal Intubation Under General Anesthesia, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
. The optimal position of the endotracheal tube (ETT) within the trachea is the middle third portion, distal to the vocal cords. In addition to clinical assessments, methods such as posteroanterior chest radiography (PA-CXR) and fiberoptic bronchoscopy (FOB) can be used to verify ETT placement. Read more about this study
- Who is it for?
- Ages 1 year to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Surgical Procedures Requiring Endotracheal Intubation Under General Anesthesia
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 31 Dec 2024
- 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 1 year to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Between 1 and 4years of ages pediatric patients scheduled for elective surgery under general anesthesia
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status 1 , 2 or 3
- Patients scheduled for elective surgical procedures
- Informed consent must be obtained from both the patient and, if applicable, their parent or guardian.
Who cannot join
- Patients under 1 year old or over 4 years old
- Patients with tracheobronchial anomalies
- Patients with vertebral column anomalies
- Patients with a history of tracheostomy and difficult intubation
- Patients who do not want to be included in the study
- Children with finger anomalies and syndromic associations
- Cases requiring nasal intubation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University School Of Medicine
Ankara, Ankara, 06100
About this study
Official title: Comparison of Optimal Endotracheal Tube Depth Using Four Different Formulas (Based on Age, Height, Weight, and Third Finger Length) in Children Aged 1-4 Years and Verification With Fiberoptic Bronchoscopy
. The optimal position of the endotracheal tube (ETT) within the trachea is the middle third portion, distal to the vocal cords. In addition to clinical assessments, methods such as posteroanterior chest radiography (PA-CXR) and fiberoptic bronchoscopy (FOB) can be used to verify ETT placement.
In our study, we aim to explain the relationship between the most accurate endotracheal tube depth and various formulas by using fiberoptic bronchoscopy, with the help of four different formulas based on age, height, weight, and third finger length.The study further seeks to:
- To identify the most accurate formula for estimating ETT placement depth in the pediatric population living in Turkey.
- To reduce the potential complications that may arise from incorrect ETT depth.
- To determine which formula, when verified by fiberoptic bronchoscopy, is also consistent with auscultation findings-especially in situations where chest radiography or fiberoptic bronchoscopy may not be readily available.
- Keywords
- Pediatric airway, endotracheal tube, intubation depth
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the correct depth of endotracheal tube insertion
This study aims to identify the optimal endotracheal tube insertion depth in pediatric patients by evaluating tracheal dimensions using fiberoptic bronchoscopy.
Measured: only once
A comparative analysis of four formulas used to determine endotracheal tube positioning
This study aims to identify the most accurate formula for estimating the ideal endotracheal tube depth among those based on age, weight, height, and middle finger length."
Measured: only once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 May 2023
- Primary completion31 Jul 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Surgical Procedures Requiring Endotracheal Intubation Under General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Can, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937840
- Sponsor's protocol ID
- AU-AR-OC-03
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Optimal Endotracheal Tube Depth Using Four Different Formulas (Based on Age, Height, Weight, and Third Finger Length) in Children Aged 1-4 Years and Verification With Fiberoptic Bronchoscopy
- ClinicalTrials.gov ID
- NCT06937840
- Acronym / sponsor ID
- AU-AR-OC-03
- Keywords
- Pediatric airway, endotracheal tube, intubation depth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Apr 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.
. The optimal position of the endotracheal tube (ETT) within the trachea is the middle third portion, distal to the vocal cords. In addition to clinical assessments, methods such as posteroanterior chest radiography (PA-CXR) and fiberoptic bronchoscopy (FOB) can be used to verify ETT placement.
In our study, we aim to explain the relationship between the most accurate endotracheal tube depth and various formulas by using fiberoptic bronchoscopy, with the help of four different formulas based on age, height, weight, and third finger length.The study further seeks to:
- To identify the most accurate formula for estimating ETT placement depth in the pediatric population living in Turkey.
- To reduce the potential complications that may arise from incorrect ETT depth.
- To determine which formula, when verified by fiberoptic bronchoscopy, is also consistent with auscultation findings-especially in situations where chest radiography or fiberoptic bronchoscopy may not be readily available.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Between 1 and 4years of ages pediatric patients scheduled for elective surgery under general anesthesia
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status 1 , 2 or 3
- Patients scheduled for elective surgical procedures
- Informed consent must be obtained from both the patient and, if applicable, their parent or guardian.
Key exclusion criteria (7 listed)
- Patients under 1 year old or over 4 years old
- Patients with tracheobronchial anomalies
- Patients with vertebral column anomalies
- Patients with a history of tracheostomy and difficult intubation
- Patients who do not want to be included in the study
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
To determine the correct depth of endotracheal tube insertion
Time frame: only once
This study aims to identify the optimal endotracheal tube insertion depth in pediatric patients by evaluating tracheal dimensions using fiberoptic bronchoscopy.
A comparative analysis of four formulas used to determine endotracheal tube positioning
Time frame: only once
This study aims to identify the most accurate formula for estimating the ideal endotracheal tube depth among those based on age, weight, height, and middle finger length."
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 25 Apr 2025.
- Individual participant dataSharing planned: Undecided
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 Pediatric Surgical Procedures Requiring Endotracheal Intubation Under General Anesthesia, run by Ankara 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 3 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: finished, as of the sponsor's last update on 25 Apr 2025. 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?
To determine the correct depth of endotracheal tube insertion (time frame: only once). The study lists 2 primary outcomes in all. 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 25 Apr 2025.