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Comparison of Modified Broselow Tape and Cole Formula

U

University of Indonesia (UI)

Status

Completed

Conditions

Predicting Uncuffed Endotracheal Tube Size in Pediatric Anesthesia

Treatments

Procedure: Cole Formula
Procedure: Modification Broselow Tape

Study type

Interventional

Funder types

Other

Identifiers

NCT04869410
IndonesiaUAnes103

Details and patient eligibility

About

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

Full 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.

Enrollment

110 patients

Sex

All

Ages

1 to 6 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

110 participants in 2 patient groups

Broselow Tape
Active Comparator group
Description:
Patient will given an intubation using uncuffed endotracheal tube size based on Modified Broselow Tape
Treatment:
Procedure: Cole Formula
Procedure: Modification Broselow Tape
Cole Formula
Active Comparator group
Description:
Patient will given an intubation using uncuffed endotracheal tube size based on Cole Formula
Treatment:
Procedure: Cole Formula
Procedure: Modification Broselow Tape

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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