Correlation Between Anthropometric Characteristics and Age-based Formulas for Uncuffed Pediatric Endotracheal Tube

NCT07349953 | Completed

• 1 other identifier: 8/148
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endotracheal Tube; Finger

Keywords

Uncuffed endotracheal tube; age-based formula; Circumference of finger

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  Day 1

• determining the correlation between the size of the selected tube and body weight

  Day 1

• determining the correlation between the size of the selected tube and body height

  Day 1

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Day - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All patients in this study were admitted to tertiray medical center for scheduled surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mother and Child Health Institute of Serbia Dr Vukan Cupic: lead

Study Sites (1)

Institute for mother and child health care

Belgrade, 11000, Serbia

Location

Related Publications (3)

• 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.

  PMID: 36317427 RESULT

• Zhou 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.

  PMID: 36340734 RESULT

• Hanamoto 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.

  PMID: 31390987 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: January 20, 2026
• Study Start: July 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 10, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD and supporting information will be available after publishing the paper Start date 1.7.2026.
• Access Criteria: Access to the IPD will be available for other researchres who are in the ORCID database

Locations

SE (1)