Prediction of Optimal Pediatric Endotracheal Tube Size "Aged Based Formula Versus Ultrasonography"

NCT03676387 | Completed DMC

• 1 other identifier: MansouraU1
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Ultrasound (US) imaging technique has recently emerged as a novel, simple, portable, noninvasive tool helpful for airway assessment and management. Initial few published reports were on soft tissue imaging of neck, focusing on pre-tracheal structure and anterior tracheal wall. In our study, we compared the measurement of subglottic diameter using ultrasonography and the aged based formula in prediction of endotracheal tube size in children underwent elective surgical operation under general anesthesia. Methods: Patients were randomly divided in 2 groups (27 patients each) using a computer-generated randomization schedule. The first group was aged based group (group AB) (n = 27): the endotracheal tube size was determined according to age of the child \[inner diameter \[ID\] in mm = (age in yr/4) +4. The second group was ultrasound based group (group UB) (n = 27): the endotracheal tube size was determined according to the subglottic transverse diameter that was estimated with ultrasonography (the outer diameter of endotracheal tube (ETT OD) = 0.55\*(subglottic diameter)+1.16) .

Conditions

Anesthesia Intubation Complication

Keywords

pediatric; endotracheal tube; ultrasonography

Outcome Measures

Primary Outcomes (2)

• 1- Number of optimum tube selection was monitored in both group (group AB and group UB) (number and percentage %).

  1 year

• Number of reintubation due to large or small tube (number and percentage %).

  1 year

Secondary Outcomes (2)

• Time of intubation (minutes).

  1 year

• complication after extubation

  1 year

Study Arms (2)

Aged based group (group AB) (n = 27)

NO INTERVENTION

ETT size was determined according to age

Ultrasound based group (group UB) (n = 27): ETT was determined

ACTIVE COMPARATOR

ETT was determined according to the subglottic transverse diameter that was estimated with ultrasonography.

Other: ultrasound guided

Interventions

ultrasound guided OTHER

Ultrasonography technique: The subglottic diameter was estimated with B-mode ultrasonography (Korean, Siemens, Acuson, x300) with a 10-13-MHz linear probe positioned on the midline of the anterior neck (figure1). The evaluation began by identifying the true vocal folds as paired hyperechoic linear structures that moved with respiration and swallowing before patients were paralyzed. The probe was then moved caudally to visualize the cricoid arch which appears as an arched, rounded and hypoechoic structure (figure2). The transverse air-column diameter was measured at the lower edge of the cricoid cartilage after patients were paralyzed (figure3). The measurements of the subglottic diameter was used to select the outer diameter of endotracheal tube by the equation \[ETT OD=0.55\*(subglottic diameter)+1.16\] (Shibasaki et al., 2010), since the outer diameter of endotracheal tube differs among different manufactures, we used uncuffed Mallinckrodt tracheal tube with a Murphy's eyes.

Ultrasound based group (group UB) (n = 27): ETT was determined

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• fifty four children aged from 1 to 6 years of either sex
• scheduled for elective surgery not exceeded 90 minutes
• underwent general anesthesia with uncuffed endotracheal tube.

You may not qualify if:

• an anticipated difficult airway
• any respiratory disease that might cause airway narrowing
• pre-exiting laryngeal or tracheal pathology
• any lesion that could cause airway deformity due to fibrosis or the presence of a neck anatomical pathologies that might have unpredictable effect on the ultrasound assessment of the airway
• prolonged surgery more than 90 minutes .

Sponsors & Collaborators

• Mansoura University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 18, 2018
• Study Start: April 1, 2016
• Primary Completion: April 16, 2017
• Study Completion: April 16, 2017
• Last Updated: September 18, 2018

Record last verified: 2018-09