Clinical Trials Directory

Trials / Completed

CompletedNCT02754531

Ultrasonography vs Cole Formula to Predict Endotracheal Tube Diameter

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Indonesia University · Academic / Other
Sex
All
Age
1 Year – 6 Years
Healthy volunteers
Not accepted

Summary

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

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).

Conditions

Interventions

TypeNameDescription
DEVICEUSGUSG 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.
OTHERCole FormulaInternal diameter of the uncuffed endotracheal tube equals (age in years/4) + 4mm.

Timeline

Start date
2016-05-01
Primary completion
2016-07-01
Completion
2016-07-01
First posted
2016-04-28
Last updated
2017-03-03

Locations

1 site across 1 country: Indonesia

Source: ClinicalTrials.gov record NCT02754531. Inclusion in this directory is not an endorsement.