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Completed

NCT Number: NCT04869410

Comparison of Modified Broselow Tape and Cole Formula

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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Key information

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospotal

Jakarta Pusat, DKI Jaka, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modification Broselow Tape

Procedure

Intubation using modified Broselow Tape prediction for predicting ETT size

Cole Formula

Procedure

Intubation using Cole Formula prediction for predicting ETT size

Primary outcomes

  1. Appropriate size of uncuffed endotracheal tube

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Accuracy of Broselow Tape and Cole Formulation in Predicting Uncuffed Endotracheal Tube Size in Pediatric Patients

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 3, 2021
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.