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Completed

NCT Number: NCT02754531

Ultrasonography vs Cole Formula to Predict Endotracheal Tube Diameter

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

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Key information

Conditions

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Cole Formula

Other

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

Primary outcomes

  1. The accuracy proportion of USG and Cole Formula

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 28, 2016
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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