Comparison of Modified Broselow Tape and Cole Formula

Not Applicable

Completed

• Conditions: Predicting Uncuffed Endotracheal Tube Size in Pediatric Anesthesia
• Interventions: Procedure: Modification Broselow Tape; Procedure: Cole Formula

• Registration Number: NCT04869410
• Lead Sponsor: Indonesia University

Brief Summary

This study aimed to determine the accuracy of modified Broselow tape measurements compared to Cole formula in predicting the size of uncuffed endotracheal tubes in Indonesian pediatrics

Detailed Description

110 subjects were given informed consent before enrolling the study and randomized into two groups, modified Broselow Tape and Cole formula. Preoperatively, prediction of suitable ETT size was performed based on Cole formula and Modified Broselow Tape. In the operating theatre, general anesthesia induction was performed with sevoflurane 4-8 vol%, fentanyl 2 μcg/kg BW, and atracurium 0.5 mg/kg BW. Laryngoscopy was performed, and an uncuffed polyvinyl chloride endotracheal tubes, whose size was based on the Cole formula, was inserted. An appropriate size of the endotracheal tube was confirmed if the endotracheal tube could go through the cricoid ring smoothly, and no air leakage found when ventilating with an inspiratory pressure of 15-20 cmH2O. The surgery and anesthesia would proceed if the correct size of the endotracheal tube were successfully inserted. If the tube couldn't pass the cricoid smoothly or air leakage was found when ventilated with an inspiratory pressure of 15-20 cmH2O, the endotracheal tube should be replaced with a bigger or smaller size.

Study Timeline

• Study Start: 2018-08-15
• Primary Completion: 2018-10-18
• Study Completion: 2019-01-10
• Status Verified: 2021-04
• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Last Update Submitted: 2021-04-28
• Study First Posted: 2021-05-03
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• pediatrics aged 1 - 6 y o
• ASA I-II
• patients went through elective surgery with Genaral anesthesia
• Need to intubated with uncuffed ETT

Exclusion Criteria

• patients with growth and development disorders
• patients whom height that was out of range in modified Broselow tape
• patients with possible airway difficulty or obstruction
• patients with respiratory diseases, underweight and obese

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Broselow Tape	Modification Broselow Tape	Patient will given an intubation using uncuffed endotracheal tube size based on Modified Broselow Tape
Cole Formula	Modification Broselow Tape	Patient will given an intubation using uncuffed endotracheal tube size based on Cole Formula
Cole Formula	Cole Formula	Patient will given an intubation using uncuffed endotracheal tube size based on Cole Formula
Broselow Tape	Cole Formula	Patient will given an intubation using uncuffed endotracheal tube size based on Modified Broselow Tape

Primary Outcome Measures

Name	Time	Method
Appropriate size of uncuffed endotracheal tube	before procedure	endotracheal tube could go through the cricoid ring smoothly, and no air leakage found when ventilating with an inspiratory pressure of 15-20 cmH2O

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospotal; 🇮🇩 Jakarta Pusat, DKI Jaka, Indonesia