Ultrasonography vs Cole Formula to Predict Endotracheal Tube Diameter

Universitas Indonesia60 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

General Anesthesia

Interventions

USGDEVICE

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.

Cole FormulaOTHER

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

Eligibility

Sex: ALLMin age: 1 YearMax age: 6 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

The accuracy proportion of USG and Cole Formula

Whether the USG measurement and Cole Formula measurement accurate or not will be recorded.

Time frame: 3 months

Data from ClinicalTrials.gov

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