Ultrasonography vs Cole Formula to Predict Endotracheal Tube Diameter

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

Detailed Description
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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).

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

Conditions
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General Anesthesia

Intervention / Treatment
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* Device: USG
* Other: Cole Formula


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects<br>USG was used to measure the internal transversal subglottic diameter on the crichoid cartilago level while the head was in sniffing position. After USG measurement was recorded, Cole formula was used to measure internal diameter of uncuffed endotracheal tube. | Device: USG<br>* 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.<br>Other: Cole Formula<br>* Internal diameter of the uncuffed endotracheal tube equals (age in years/4) + 4mm.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cole formula, Pediatric patients, intubation, Ultrasonography, Endotracheal tube, uncuffed, pediatric