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General AnesthesiaNCT02754531

Ultrasonography vs Cole Formula to Predict Endotracheal Tube Diameter

A study testing USG and Cole Formula in people with General Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 1 year to 6 years
Conditions the study is for
General Anesthesia
What is being tested?
USG and Cole Formula
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteIndonesia
Study dates
May 2016to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 9Show fewer
  • Drop out criteria:
  • Subjects with cardiorespiratory disorder during intubation
  • Subjects who were failed to be intubated twice.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Cipto Mangunkusumo Cental National Hospital

    Jakarta, DKI Jakarta, 10430

Other trials in Indonesia

About this study

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

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

Read the detailed 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).

Being tested
USG, Cole Formula
Keywords
Cole formula, Pediatric patients, intubation, Ultrasonography, Endotracheal tube, uncuffed, pediatric

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • USGDevice

    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.

  • Cole FormulaOther

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

Study groups in NCT02754531
Study groupRoleWhat they receive
SubjectsExperimentalUSG 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.
Receives: Device: USG; Other: Cole Formula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The accuracy proportion of USG and Cole Formula

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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02754531
Sponsor's protocol ID
IndonesiaUAnes006
Status last verified
Mar 2017
First submitted
26 Apr 2016
Last updated
3 Mar 2017
Results posted
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25885609

  • 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.

    PubMed 23965215

  • 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.

    PubMed 13478300

  • 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.

    PubMed 19178655

  • 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.

    PubMed 9254579

  • 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.

    PubMed 20808208

  • 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.

    PubMed 21933159

  • 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.

    PubMed 22612446

  • 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.

    PubMed 4713016

  • 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.

    PubMed 22802851

  • 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.

    PubMed 25894917

  • 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.

    PubMed 19572839

  • 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.

    PubMed 21705729

  • 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.

    PubMed 20040778

  • 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.

    PubMed 24533395

Questions about this trial

What is this clinical trial studying?

A study testing USG and Cole Formula in people with General Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The accuracy proportion of USG and Cole Formula (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02754531, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.

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