Ultrasonography vs Cole Formula to Predict Endotracheal Tube Diameter

Not Applicable

Completed

• Conditions: General Anesthesia
• Interventions: Device: USG; Other: Cole Formula

• Registration Number: NCT02754531
• Lead Sponsor: Indonesia University

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).

Study Timeline

• Study First Submitted: 2016-04-26
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-04-28
• Study Start: 2016-05
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects	USG	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.
Subjects	Cole Formula	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cipto Mangunkusumo Cental National Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia