Clinical Trials Directory

Trials / Completed

CompletedNCT04869410

Comparison of Modified Broselow Tape and Cole Formula

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
110 (actual)
Sponsor
Indonesia University · Academic / Other
Sex
All
Age
1 Year – 6 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREModification Broselow TapeIntubation using modified Broselow Tape prediction for predicting ETT size
PROCEDURECole FormulaIntubation using Cole Formula prediction for predicting ETT size

Timeline

Start date
2018-08-15
Primary completion
2018-10-18
Completion
2019-01-10
First posted
2021-05-03
Last updated
2021-05-03

Locations

1 site across 1 country: Indonesia

Source: ClinicalTrials.gov record NCT04869410. Inclusion in this directory is not an endorsement.