Endotracheal TubeNCT07349953
Correlation Between Anthropometric Characteristics and Age-based Formulas for Uncuffed Pediatric Endotracheal Tube
An observational study of Endotracheal Tube and Finger, run by Mother and Child Health Institute of Serbia Dr Vukan Cupic at 1 site in Serbia.
Trial summary
The goal of this observational study is to investigate the correlation between anthropometric characteristics, such as finger circumferences, body weight, body height, and body mass index, and age-based formulas for uncuffed tube size in pediatric patients up to 8 years of age. Read more about this study
- Who is it for?
- Ages 1 day to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Tube, Finger
- How many people
- 103 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Jul 2025to 10 Oct 2025
- How long will I take part?
- 1 Day
- 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 day to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All patients in this study were admitted to tertiray medical center for scheduled surgery.
Who may be able to join
- Age up to 8 years of age;
- Children without congenital and acquired anomalies of the trachea;
- Children in whom tracheal intubation is planned as part of the anesthesia plan
Who cannot join
- Age over 8 years of age;
- The presence of congenital and acquired anomalies of the trachea;
- Children who are already intubated; and failure to obtain informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimation of Correlation Betweeen Antropometric Characteristics of Children up to 8 Years and Age-based Formulas for Uncuffed Endotracheal Tube in Elective Intubated Children During General Anesthesia
The goal of this observational study is to investigate the correlation between anthropometric characteristics, such as finger circumferences, body weight, body height, and body mass index, and age-based formulas for uncuffed tube size in pediatric patients up to 8 years of age.
Read the detailed description
Patients who met inclusion criteria entered the study. All included patients were premedicated with midazolam 0.1mg/kg IV 30 minutes before general anesthesia. Induction: propofol 2,5mg/kg IV, rocuronium 0,6mg/kg IV, fentanyl 3mcg/kg IV; maintenance: sevoflurane 1vol% - 2vol%, fentanyl 3mcg/kg IV as needed. reversion of neuromuscular block was achieved using sugammadex. Trachea was intubated using direct laryngoscopy. Intubation performed one anesthesiologist with more than 10 years of clinical experience in pediatric anesthesia. Initial choice of endotracheal tube (ET) was based on the size of little finger. Proper position of ET was confirmed with chest auscultation, capnography and capnometry. If placing ET was difficult or air leak was not detected using inspiratory pressure > 25cmH2O,ET was replaced with 0,5mm smaller one. If there was air leak using inspiratory pressure < 10 mmHg ET was replaced with 0.5mm bigger one. All children were ventilated using protective strategy. After intubation, measures were made:
- Finger's circumference was measured with flexible ruler tape (in millimeters). The tape was wrapped around the base of the finger. Circumferences of index finger, middle finger, ring finger and small finger were documented for each hand.
- Data of body weight, body height and body mass index were taken from patients history.
- Sizes of used endotracheal tubes were documented.
- Calculations of ET tube size using age based formulas were made: for children over 2 years ID (mm) = god/4+4 for children under 2 years of age ODcal (mm) = 0,00223x age(days)+4.88
- Conditions
- Endotracheal Tube, Finger
- Keywords
- Uncuffed endotracheal tube, age-based formula, Circumference of finger
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 |
|---|---|---|
| Peditric patients up to 8 years of age requiuring general anesthesia with endotracheal intubation | All patients were scheduled for surgery and elective intubation. Patient's body weight, height, body mass index, and finger circumference were documented. The tube size was selected based on an appropriate formula. After intubation, the circumference of the index, middle, ring, and little fingers of the right and left hands, as well as the child's body mass and height, were measured. The measurement was performed using a flexible meter at the joint of the palm and the root of the finger. Only one anesthesiologist performed the intubation. If the placement of the tube was difficult or there was no audible air leakage around the tube at an inspiratory pressure > 20cmH2O, the selected tube was replaced with a smaller tube by 0.5 mm. If an audible air leak was documented after intubation at an inspiratory pressure of < 10 mmHg, the tube was replaced with a larger tube by 0.5 mm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study was determining the correlation between the size of the selected tube and the circumference of the little finger of the right and left hand
Measured: Day 1
Secondary outcomes (7)
determining the correlation between the size of the selected tube and the circumference of the index finger of the right and left hand
Measured: Day 1
determining the correlation between the size of the selected tube and the circumference of the middle finger of the right and left hand
Measured: Day 1
Determining the correlation between the size of the selected tube and the circumference of the ring finger of the right and left hand
Measured: Day 1
determining the correlation between the size of the selected tube and body weight
Measured: Day 1
determining the correlation between the size of the selected tube and body height
Measured: Day 1
Determining the frequency of post-treatment complications of hoarseness, cough and sore throat
Measured: Day 1
determining the frequency of reintubation
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jul 2025
- Primary completion1 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endotracheal TubeStudies 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
- 103 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Mother and Child Health Institute of Serbia Dr Vukan Cupic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Mandras, Mother and Child Health Institute of Serbia Dr Vukan Cupic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349953
- Sponsor's protocol ID
- 8/148
- Status last verified
- Jan 2026
- First submitted
- 14 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD can be requested by contacting the principal investigator via email: ana\_mandras@yahoo.com
Publications
Park S, Shin SW, Kim HJ, Byeon GJ, Yoon JU, Kim EJ, Kim HY. Choice of the correct size of endotracheal tube in pediatric patients. Anesth Pain Med (Seoul). 2022 Oct;17(4):352-360. doi: 10.17085/apm.22215. Epub 2022 Oct 26.
PubMed 36317427Zhou M, Xu WY, Xu S, Zang QL, Li Q, Tan L, Hu YC, Ma N, Xia JH, Liu K, Ye M, Pu FY, Chen L, Song LJ, Liu Y, Jiang L, Gu L, Zou Z. Prediction of endotracheal tube size in pediatric patients: Development and validation of machine learning models. Front Pediatr. 2022 Oct 20;10:970646. doi: 10.3389/fped.2022.970646. eCollection 2022.
PubMed 36340734Hanamoto H, Maegawa H, Inoue M, Oyamaguchi A, Kudo C, Niwa H. Age-based prediction of uncuffed tracheal tube size in children to prevent inappropriately large tube selection: a retrospective analysis. BMC Anesthesiol. 2019 Aug 7;19(1):141. doi: 10.1186/s12871-019-0818-3.
PubMed 31390987
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Correlation Betweeen Antropometric Characteristics of Children up to 8 Years and Age-based Formulas for Uncuffed Endotracheal Tube in Elective Intubated Children During General Anesthesia
- ClinicalTrials.gov ID
- NCT07349953
- Acronym / sponsor ID
- 8/148
- Conditions
- Endotracheal Tube, Finger
- Keywords
- Uncuffed endotracheal tube, age-based formula, Circumference of finger
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Mother and Child Health Institute of Serbia Dr Vukan CupicUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 20 Jan 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.
The goal of this observational study is to investigate the correlation between anthropometric characteristics, such as finger circumferences, body weight, body height, and body mass index, and age-based formulas for uncuffed tube size in pediatric patients up to 8 years of age.
Detailed description
Patients who met inclusion criteria entered the study. All included patients were premedicated with midazolam 0.1mg/kg IV 30 minutes before general anesthesia. Induction: propofol 2,5mg/kg IV, rocuronium 0,6mg/kg IV, fentanyl 3mcg/kg IV; maintenance: sevoflurane 1vol% - 2vol%, fentanyl 3mcg/kg IV as needed. reversion of neuromuscular block was achieved using sugammadex. Trachea was intubated using direct laryngoscopy. Intubation performed one anesthesiologist with more than 10 years of clinical experience in pediatric anesthesia. Initial choice of endotracheal tube (ET) was based on the size of little finger. Proper position of ET was confirmed with chest auscultation, capnography and capnometry. If placing ET was difficult or air leak was not detected using inspiratory pressure > 25cmH2O,ET was replaced with 0,5mm smaller one. If there was air leak using inspiratory pressure < 10 mmHg ET was replaced with 0.5mm bigger one. All children were ventilated using protective strategy. After intubation, measures were made:
- Finger's circumference was measured with flexible ruler tape (in millimeters). The tape was wrapped around the base of the finger. Circumferences of index finger, middle finger, ring finger and small finger were documented for each hand.
- Data of body weight, body height and body mass index were taken from patients history.
- Sizes of used endotracheal tubes were documented.
- Calculations of ET tube size using age based formulas were made: for children over 2 years ID (mm) = god/4+4 for children under 2 years of age ODcal (mm) = 0,00223x age(days)+4.88
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peditric patients up to 8 years of age requiuring general anesthesia with endotracheal intubation | – | –All patients were scheduled for surgery and elective intubation. Patient's body weight, height, body mass index, and finger circumference were documented. The tube size was selected based on an appropriate formula. After intubation, the circumference of the index, middle, ring, and little fingers of the right and left hands, as well as the child's body mass and height, were measured. The measurement was performed using a flexible meter at the joint of the palm and the root of the finger. Only one anesthesiologist performed the intubation. If the placement of the tube was difficult or there was no audible air leakage around the tube at an inspiratory pressure > 20cmH2O, the selected tube was replaced with a smaller tube by 0.5 mm. If an audible air leak was documented after intubation at an inspiratory pressure of < 10 mmHg, the tube was replaced with a larger tube by 0.5 mm. |
Who may qualify
- Ages
- 1 day to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All patients in this study were admitted to tertiray medical center for scheduled surgery.
Key inclusion criteria (3 listed)
- Age up to 8 years of age;
- Children without congenital and acquired anomalies of the trachea;
- Children in whom tracheal intubation is planned as part of the anesthesia plan
Key exclusion criteria (3 listed)
- Age over 8 years of age;
- The presence of congenital and acquired anomalies of the trachea;
- Children who are already intubated; and failure to obtain 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
The primary outcome of the study was determining the correlation between the size of the selected tube and the circumference of the little finger of the right and left hand
Time frame: Day 1
7 secondary outcomes
determining the correlation between the size of the selected tube and the circumference of the index finger of the right and left hand
Time frame: Day 1
determining the correlation between the size of the selected tube and the circumference of the middle finger of the right and left hand
Time frame: Day 1
Determining the correlation between the size of the selected tube and the circumference of the ring finger of the right and left hand
Time frame: Day 1
determining the correlation between the size of the selected tube and body weight
Time frame: Day 1
determining the correlation between the size of the selected tube and body height
Time frame: Day 1
Determining the frequency of post-treatment complications of hoarseness, cough and sore throat
Time frame: Day 1
determining the frequency of reintubation
Time frame: Day 1
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 20 Jan 2026.
- Results publication: PubMed 36317427Park S, Shin SW, Kim HJ, Byeon GJ, Yoon JU, Kim EJ, Kim HY. Choice of the correct size of endotracheal tube in pediatric patients. Anesth Pain Med (Seoul). 2022 Oct;17(4):352-360. doi: 10.17085/apm.22215. Epub 2022 Oct 26.
- Results publication: PubMed 36340734Zhou M, Xu WY, Xu S, Zang QL, Li Q, Tan L, Hu YC, Ma N, Xia JH, Liu K, Ye M, Pu FY, Chen L, Song LJ, Liu Y, Jiang L, Gu L, Zou Z. Prediction of endotracheal tube size in pediatric patients: Development and validation of machine learning models. Front Pediatr. 2022 Oct 20;10:970646. doi: 10.3389/fped.2022.970646. eCollection 2022.
- Results publication: PubMed 31390987Hanamoto H, Maegawa H, Inoue M, Oyamaguchi A, Kudo C, Niwa H. Age-based prediction of uncuffed tracheal tube size in children to prevent inappropriately large tube selection: a retrospective analysis. BMC Anesthesiol. 2019 Aug 7;19(1):141. doi: 10.1186/s12871-019-0818-3.
- Individual participant dataSharing planned: Yes. IPD can be requested by contacting the principal investigator via email: ana_mandras@yahoo.com
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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 Endotracheal Tube and Finger, run by Mother and Child Health Institute of Serbia Dr Vukan Cupic at 1 site in Serbia.
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 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 20 Jan 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 Serbia. 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?
The primary outcome of the study was determining the correlation between the size of the selected tube and the circumference of the little finger of the right and left hand (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07349953, which also lists 3 linked publications.
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 20 Jan 2026.