Clinical trial NCT04869410: Comparison of Modified Broselow Tape and Cole Formula
Official title: Accuracy of Broselow Tape and Cole Formulation in Predicting Uncuffed Endotracheal Tube Size in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Predicting Uncuffed Endotracheal Tube Size in Pediatric Anesthesia
Keywords: Uncuffed endotracheal tube
Pediatric
Cole Formula
Broselow Tape
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 110
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Appropriate size of uncuffed endotracheal tube
timeFrame: before procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospotal
state: DKI Jaka
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.