Ultrasonography vs Cole Formula to Predict Endotracheal Tube Diameter

NCT02754531 | Completed

• 1 other identifier: IndonesiaUAnes006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the accuracy of measurement between ultrasonography and Cole formula in predicting uncuffed endotracheal tube diameter.

Conditions

General Anesthesia

Keywords

Cole formula; Pediatric patients; intubation; Ultrasonography; Endotracheal tube; uncuffed; pediatric

Outcome Measures

Primary Outcomes (1)

• The accuracy proportion of USG and Cole Formula

  Whether the USG measurement and Cole Formula measurement accurate or not will be recorded.

  3 months

Study Arms (1)

Subjects

EXPERIMENTAL

USG was used to measure the internal transversal subglottic diameter on the crichoid cartilago level while the head was in sniffing position. After USG measurement was recorded, Cole formula was used to measure internal diameter of uncuffed endotracheal tube.

Device: USG; Other: Cole Formula

Interventions

USG DEVICE

USG used was SonoSite® M-Turbo Bothell, WA, USA, probe linear (Array HFL 38 frekuensi 6-13 MHz). Internal subglottic diameter equals external diameter of the uncuffed endotracheal tube or trachea diameter, result rounded to the smallest uncuffed endotracheal tube size.

Subjects

Cole Formula OTHER

Internal diameter of the uncuffed endotracheal tube equals (age in years/4) + 4mm.

Subjects

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects aged 1-6 years old, Malayan race, planned to undergo elective surgery with general anesthesia with intubation
• Subjects with ASA status I-II
• Cooperative subjects
• Subjects whose parents had signed the informed consent

You may not qualify if:

• Subjects with allergies to Ultrasonography jelly
• Subjects with difficult airway
• Subjects with mass in the neck area
• Subjects with respiratory diseases
• Subjects with growth \& development disorders
• Subjects with malnutrition (\<5% percentile) and obesity (\>95% percentile).
• Drop out criteria:
• Subjects with cardiorespiratory disorder during intubation
• Subjects who were failed to be intubated twice.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (17)

• Gupta K, Gupta PK, Rastogi B, Krishan A, Jain M, Garg G. Assessment of the subglottic region by ultrasonography for estimation of appropriate size endotracheal tube: A clinical prospective study. Anesth Essays Res. 2012 Jul-Dec;6(2):157-60. doi: 10.4103/0259-1162.108298.

  PMID: 25885609 BACKGROUND

• Park HP, Hwang JW, Lee JH, Nahm FS, Park SH, Oh AY, Jeon YT, Lim YJ. Predicting the appropriate uncuffed endotracheal tube size for children: a radiograph-based formula versus two age-based formulas. J Clin Anesth. 2013 Aug;25(5):384-387. doi: 10.1016/j.jclinane.2013.01.015. Epub 2013 Aug 17.

  PMID: 23965215 BACKGROUND

• COLE F. Pediatric formulas for the anesthesiologist. AMA J Dis Child. 1957 Dec;94(6):672-3. doi: 10.1001/archpedi.1957.04030070084009. No abstract available.

  PMID: 13478300 BACKGROUND

• Eipe N, Barrowman N, Writer H, Doherty D. A weight-based formula for tracheal tube size in children. Paediatr Anaesth. 2009 Apr;19(4):343-8. doi: 10.1111/j.1460-9592.2008.02916.x. Epub 2009 Jan 21.

  PMID: 19178655 BACKGROUND

• van den Berg AA, Mphanza T. Choice of tracheal tube size for children: finger size or age-related formula? Anaesthesia. 1997 Jul;52(7):701-3. doi: 10.1111/j.1365-2044.1997.az0130c.x.

  PMID: 9254579 BACKGROUND

• Shibasaki M, Nakajima Y, Ishii S, Shimizu F, Shime N, Sessler DI. Prediction of pediatric endotracheal tube size by ultrasonography. Anesthesiology. 2010 Oct;113(4):819-24. doi: 10.1097/ALN.0b013e3181ef6757.

  PMID: 20808208 BACKGROUND

• Bae JY, Byon HJ, Han SS, Kim HS, Kim JT. Usefulness of ultrasound for selecting a correctly sized uncuffed tracheal tube for paediatric patients. Anaesthesia. 2011 Nov;66(11):994-8. doi: 10.1111/j.1365-2044.2011.06900.x. Epub 2011 Sep 20.

  PMID: 21933159 BACKGROUND

• 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: 22612446 BACKGROUND

• Delilkan AE. Choice of endotracheal tube in the Malaysian paediatric patient--a guide. Singapore Med J. 1973 Mar;14(1):26-8. No abstract available.

  PMID: 4713016 BACKGROUND

• Zahedi-Nejad N, Bakhshayesh-Karam M, Kahkoei S, Abbasi-Dezfoully A, Masjedi MR. Normal dimensions of trachea and two main bronchi in the Iranian population. Pol J Radiol. 2011 Oct;76(4):28-31.

  PMID: 22802851 BACKGROUND

• Mi W, Zhang C, Wang H, Cao J, Li C, Yang L, Guo F, Wang X, Yang T. Measurement and analysis of the tracheobronchial tree in Chinese population using computed tomography. PLoS One. 2015 Apr 20;10(4):e0123177. doi: 10.1371/journal.pone.0123177. eCollection 2015.

  PMID: 25894917 BACKGROUND

• Adewale L. Anatomy and assessment of the pediatric airway. Paediatr Anaesth. 2009 Jul;19 Suppl 1:1-8. doi: 10.1111/j.1460-9592.2009.03012.x.

  PMID: 19572839 BACKGROUND

• Prasad A, Yu E, Wong DT, Karkhanis R, Gullane P, Chan VW. Comparison of sonography and computed tomography as imaging tools for assessment of airway structures. J Ultrasound Med. 2011 Jul;30(7):965-72. doi: 10.7863/jum.2011.30.7.965.

  PMID: 21705729 BACKGROUND

• Singh M, Chin KJ, Chan VW, Wong DT, Prasad GA, Yu E. Use of sonography for airway assessment: an observational study. J Ultrasound Med. 2010 Jan;29(1):79-85. doi: 10.7863/jum.2010.29.1.79.

  PMID: 20040778 BACKGROUND

• Prasanna Kumar S, Ravikumar A. Biometric study of the internal dimensions of subglottis and upper trachea in adult Indian population. Indian J Otolaryngol Head Neck Surg. 2014 Jan;66(Suppl 1):261-6. doi: 10.1007/s12070-012-0477-x. Epub 2012 Jan 21.

  PMID: 24533395 BACKGROUND

• CROTEAU JR, COOK CD. Volume-pressure and length-tension measurements in human tracheal and bronchial segments. J Appl Physiol. 1961 Jan;16:170-2. doi: 10.1152/jappl.1961.16.1.170. No abstract available.

  PMID: 13696635 BACKGROUND

• Griscom NT, Wohl ME. Dimensions of the growing trachea related to age and gender. AJR Am J Roentgenol. 1986 Feb;146(2):233-7. doi: 10.2214/ajr.146.2.233.

  PMID: 3484568 BACKGROUND

Related Links

• Black A, Flynn P, Popat M, Smith H, Thomas M, Wilkinson K. Unanticipated difficult tracheal intubation - during routine induction of anaesthesia in a child aged 1 to 8 years. 2015

Study Officials

• Aida R Tantri, Consultant

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Anesthesiologist

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: April 28, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

ID (1)