Ultrasonography vs Cole Formula to Predict Endotracheal Tube Diameter

U

University of Indonesia (UI)

Status

Completed

Conditions

General Anesthesia

Treatments

Device: USG
Other: Cole Formula

Study type

Interventional

Funder types

Other

Identifiers

NCT02754531
IndonesiaUAnes006

Details and patient eligibility

About

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

Full 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).

Enrollment

60 patients

Sex

All

Ages

1 to 6 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Subjects
Experimental group
Description:
USG 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.
Treatment:
Other: Cole Formula
Device: USG

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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