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Completed

NCT Number: NCT07349953

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

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.

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Key information

Age range

1 day–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for mother and child health care

Belgrade, 11000, Serbia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

    Time frame: Day 1

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. determining the correlation between the size of the selected tube and body weight

    Time frame: Day 1

  5. determining the correlation between the size of the selected tube and body height

    Time frame: Day 1

  6. Determining the frequency of post-treatment complications of hoarseness, cough and sore throat

    Time frame: Day 1

  7. determining the frequency of reintubation

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Mother and Child Health Institute of Serbia Dr Vukan Cupic

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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