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
| Type | Name | Description |
|---|---|---|
| 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. |
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.