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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04869410
Enrollment
110
Registered
2021-05-03
Start date
2018-08-15
Completion date
2019-01-10
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Predicting Uncuffed Endotracheal Tube Size in Pediatric Anesthesia

Keywords

Uncuffed endotracheal tube, Pediatric, Cole Formula, Broselow Tape

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.

Interventions

PROCEDUREModification Broselow Tape

Intubation using modified Broselow Tape prediction for predicting ETT size

PROCEDURECole Formula

Intubation using Cole Formula prediction for predicting ETT size

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Masking description

Investigator

Eligibility

Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Appropriate size of uncuffed endotracheal tubebefore procedureendotracheal tube could go through the cricoid ring smoothly, and no air leakage found when ventilating with an inspiratory pressure of 15-20 cmH2O

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026