Comparison of Modified Broselow Tape and Cole Formula

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2019-01-10

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Predicting Uncuffed Endotracheal Tube Size in Pediatric Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Investigator

Study Groups

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Broselow Tape

Patient will given an intubation using uncuffed endotracheal tube size based on Modified Broselow Tape

Group Type ACTIVE_COMPARATOR

Modification Broselow Tape

Intervention Type PROCEDURE

Intubation using modified Broselow Tape prediction for predicting ETT size

Cole Formula

Intervention Type PROCEDURE

Intubation using Cole Formula prediction for predicting ETT size

Cole Formula

Patient will given an intubation using uncuffed endotracheal tube size based on Cole Formula

Group Type ACTIVE_COMPARATOR

Modification Broselow Tape

Intervention Type PROCEDURE

Intubation using modified Broselow Tape prediction for predicting ETT size

Cole Formula

Intervention Type PROCEDURE

Intubation using Cole Formula prediction for predicting ETT size

Interventions

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Modification Broselow Tape

Intubation using modified Broselow Tape prediction for predicting ETT size

Intervention Type PROCEDURE

Cole Formula

Intubation using Cole Formula prediction for predicting ETT size

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes