Ultrasonography vs Cole Formula to Predict Endotracheal Tube Diameter

General Anesthesia Clinical Trial

Official title:

Comparison Between Ultrasonography and Cole Formula in Predicting Uncuffed Endotracheal Tube Diameter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754531
• Other study ID #: IndonesiaUAnes006
• Status: Completed
• Phase: N/A
• First received: April 26, 2016
• Last updated: March 1, 2017
• Start date: May 2016
• Est. completion date: July 2016

Study information

• Verified date: March 2017
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Non-invasive blood pressure (NIBP) monitor, ECG and pulse-oximeter was set on the subjects in the operation room. The uncuffed endotracheal tube (ETT) diameter predictions were measured firstly using ultrasonography (USG), then with Cole formula. After that, polyvinyl chloride (Mallinckrodt) ETT intubation with Cole diameter measurement was inserted using direct laryngoscopy. If the ETT was too small, use a 0.5 mm bigger ETT than the prediction diameter, if it too big, use a 0.5 mm smaller ETT than the prediction diameter. Reintubation and measurements using both methods were recorded. If bradycardia or desaturation happened, positive pressure ventilation, 100% oxygen, atropine 0,01-0,02 mg/kg, adrenaline 0,01 mg/kg could be given. Data was analyzed using SPSS using Bivariat Chi-square test or Fisher Exact Test (categorical comparative analytical study).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Device:
• USG
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.

Other:
• Cole Formula
Internal diameter of the uncuffed endotracheal tube equals (age in years/4) + 4mm.

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Cental National Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (17)

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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. — View Citation

COLE F. Pediatric formulas for the anesthesiologist. AMA J Dis Child. 1957 Dec;94(6):672-3. — View Citation

CROTEAU JR, COOK CD. Volume-pressure and length-tension measurements in human tracheal and bronchial segments. J Appl Physiol. 1961 Jan;16:170-2. — View Citation

Delilkan AE. Choice of endotracheal tube in the Malaysian paediatric patient--a guide. Singapore Med J. 1973 Mar;14(1):26-8. — View Citation

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. — View Citation

Griscom NT, Wohl ME. Dimensions of the growing trachea related to age and gender. AJR Am J Roentgenol. 1986 Feb;146(2):233-7. — View Citation

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. — View Citation

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. Erratum in: PLoS One. 2015;10(6):e0130239. — View Citation

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):384-7. doi: 10.1016/j.jclinane.2013.01.015. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy proportion of USG and Cole Formula	Whether the USG measurement and Cole Formula measurement accurate or not will be recorded.	3 months

External 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