Ultrasonography vs Cole Formula to Predict Endotracheal Tube Diameter

Comparison Between Ultrasonography and Cole Formula in Predicting Uncuffed Endotracheal Tube Diameter

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02754531

Enrollment

Registered

2016-04-28

Start date

2016-05-31

Completion date

2016-07-31

Last updated

2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

Keywords

Cole formula, Pediatric patients, intubation, Ultrasonography, Endotracheal tube, uncuffed, pediatric

Brief summary

This study aims to compare the accuracy of measurement between ultrasonography and Cole formula in predicting uncuffed endotracheal tube diameter.

Detailed description

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Non-invasive blood pressure (NIBP) monitor, ECG and pulse-oximeter was set on the subjects in the operation room. The uncuffed endotracheal tube (ETT) diameter predictions were measured firstly using ultrasonography (USG), then with Cole formula. After that, polyvinyl chloride (Mallinckrodt) ETT intubation with Cole diameter measurement was inserted using direct laryngoscopy. If the ETT was too small, use a 0.5 mm bigger ETT than the prediction diameter, if it too big, use a 0.5 mm smaller ETT than the prediction diameter. Reintubation and measurements using both methods were recorded. If bradycardia or desaturation happened, positive pressure ventilation, 100% oxygen, atropine 0,01-0,02 mg/kg, adrenaline 0,01 mg/kg could be given. Data was analyzed using SPSS using Bivariat Chi-square test or Fisher Exact Test (categorical comparative analytical study).

Interventions

DEVICEUSG

USG used was SonoSite® M-Turbo Bothell, WA, USA, probe linear (Array HFL 38 frekuensi 6-13 MHz). Internal subglottic diameter equals external diameter of the uncuffed endotracheal tube or trachea diameter, result rounded to the smallest uncuffed endotracheal tube size.

OTHERCole Formula

Internal diameter of the uncuffed endotracheal tube equals (age in years/4) + 4mm.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 6 Years

Healthy volunteers

Inclusion criteria

* Subjects aged 1-6 years old, Malayan race, planned to undergo elective surgery with general anesthesia with intubation * Subjects with ASA status I-II * Cooperative subjects * Subjects whose parents had signed the informed consent

Exclusion criteria

* Subjects with allergies to Ultrasonography jelly * Subjects with difficult airway * Subjects with mass in the neck area * Subjects with respiratory diseases * Subjects with growth & development disorders * Subjects with malnutrition (\<5% percentile) and obesity (\>95% percentile). Drop out criteria: * Subjects with cardiorespiratory disorder during intubation * Subjects who were failed to be intubated twice.

Design outcomes

Primary

Measure	Time frame	Description
The accuracy proportion of USG and Cole Formula	3 months	Whether the USG measurement and Cole Formula measurement accurate or not will be recorded.

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026