Comparison of Modified Broselow Tape and Cole Formula

April 28, 2021 updated by: Aida Rosita Tantri, Indonesia University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jaka
      • Jakarta Pusat, DKI Jaka, Indonesia, 10430
        • Cipto Mangunkusumo Hospotal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Broselow Tape
Patient will given an intubation using uncuffed endotracheal tube size based on Modified Broselow Tape
Procedure: Modification Broselow Tape
Intubation using modified Broselow Tape prediction for predicting ETT size
Procedure: Cole Formula
Intubation using Cole Formula prediction for predicting ETT size
Active Comparator: Cole Formula
Patient will given an intubation using uncuffed endotracheal tube size based on Cole Formula
Procedure: Modification Broselow Tape
Intubation using modified Broselow Tape prediction for predicting ETT size
Procedure: Cole Formula
Intubation using Cole Formula prediction for predicting ETT size

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2018

Primary Completion (Actual)

October 18, 2018

Study Completion (Actual)

January 10, 2019

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IndonesiaUAnes103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Predicting Uncuffed Endotracheal Tube Size in Pediatric Anesthesia

Clinical Trials on Modification Broselow Tape

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe