NCT04869410

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

April 28, 2021

Last Update Submit

April 28, 2021

Conditions

Predicting Uncuffed Endotracheal Tube Size in Pediatric Anesthesia

Keywords

Uncuffed endotracheal tubePediatricCole FormulaBroselow Tape

Outcome Measures

Primary Outcomes (1)

  • Appropriate size of uncuffed endotracheal tube

    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

Study Arms (2)

Broselow Tape

ACTIVE COMPARATOR

Patient will given an intubation using uncuffed endotracheal tube size based on Modified Broselow Tape

Procedure: Modification Broselow TapeProcedure: Cole Formula

Cole Formula

ACTIVE COMPARATOR

Patient will given an intubation using uncuffed endotracheal tube size based on Cole Formula

Procedure: Modification Broselow TapeProcedure: Cole Formula

Interventions

Modification Broselow TapePROCEDURE

Intubation using modified Broselow Tape prediction for predicting ETT size

Broselow TapeCole Formula
Cole FormulaPROCEDURE

Intubation using Cole Formula prediction for predicting ETT size

Broselow TapeCole Formula

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • pediatrics aged 1 - 6 y o
  • ASA I-II
  • patients went through elective surgery with Genaral anesthesia
  • Need to intubated with uncuffed ETT

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospotal

Jakarta Pusat, DKI Jaka, 10430, Indonesia

Location

Related Publications (5)

  • Hofer CK, Ganter M, Tucci M, Klaghofer R, Zollinger A. How reliable is length-based determination of body weight and tracheal tube size in the paediatric age group? The Broselow tape reconsidered. Br J Anaesth. 2002 Feb;88(2):283-5. doi: 10.1093/bja/88.2.283.

    PMID: 11878662BACKGROUND

  • Park HP. Appropriate tube size selection based on radiological images. Korean J Anesthesiol. 2014 Mar;66(3):181-2. doi: 10.4097/kjae.2014.66.3.181. No abstract available.

    PMID: 24729837BACKGROUND

  • Schramm C, Knop J, Jensen K, Plaschke K. Role of ultrasound compared to age-related formulas for uncuffed endotracheal intubation in a pediatric population. Paediatr Anaesth. 2012 Aug;22(8):781-6. doi: 10.1111/j.1460-9592.2012.03889.x. Epub 2012 May 21.

    PMID: 22612446BACKGROUND

  • Jang HY, Shin SD, Kwak YH. Can the Broselow tape be used to estimate weight and endotracheal tube size in Korean children? Acad Emerg Med. 2007 May;14(5):489-91. doi: 10.1197/j.aem.2006.12.014. Epub 2007 Mar 23.

    PMID: 17384410BACKGROUND

  • Shih MH, Chung CY, Su BC, Hung CT, Wong SY, Wong TK. Accuracy of a new body length-based formula for predicting tracheal tube size in Chinese children. Chang Gung Med J. 2008 May-Jun;31(3):276-80.

    PMID: 18782950RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Investigator
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 3, 2021

Study Start

August 15, 2018

Primary Completion

October 18, 2018

Study Completion

January 10, 2019

Last Updated

May 3, 2021

Record last verified: 2021-04

Locations

ID(1)