Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06000267 |
Other study ID # |
UCHBelgrade |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 10, 2022 |
Est. completion date |
October 2023 |
Study information
Verified date |
September 2023 |
Source |
University Childrens Hospital Belgrade |
Contact |
Ivana Petrov, MD |
Phone |
64 152 5959 |
Email |
kikapetrov75[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The goal of this prospective, observational study is to identify predictors of difficult mask
ventilation, direct laryngoscopy and intubation in pediatric patients scheduled for elective
surgery and to determine their incidence. As a final goal, the investigators will try to
define new scoring system for difficult airway prediction. Participants will be pediatric
patients age infant till school age. Participants will have their airway assessed one day
before surgery by taking anthropometric measurements of face and neck. After iv anesthesia
induction and application of muscle relaxant, the investigators will assess difficulty of
face mask ventilation by using grading from 0-4. Direct laryngoscopy will be performed with
Macintosh blade and experienced anesthesiologist will determine Cormack - Lehane score as
well as intubation difficulty score (IDS).
Description:
Participants will be divided into groups: up to 1 yrs of age, 1-2.9 yrs, 3-4.9, 5-6.9, and 7
yrs and older.
The investigators will test predictive value, sensitivity and specificity of anthropometric
parameters used for airway assessment in pediatric patients, as well as gender, age, BMI, ASA
score.
Anatomical parameters that will be measured the day before surgery: chin, inter - incisor
gap, hyomental distance (HMD), hyoid - thyroid distance (HT), neck circumference, neck
length, neck extension, lower lip to chin distance (LCD), tragus to chin distance (TMA),
thyromental distance (TMD), sternomental distance (SMD).
Mallampati test will be performed in children older than 5 years and best oropharyngeal view
(BOV) will be determined for younger children. Colorado Pediatric Airway Score (COPUR) will
be calculated.
All patients will be premedicated with midazolam 0.5 mg/kg orally, 30 minutes before
intervention or 0.1 mg/kg iv. Anesthesia induction will be intravenous: thiopentone 5 mg/kg
or propofol 2.5 mg/kg, fentanyl 3 mcg/kg and non depolarizing muscle relaxant rocuronium 1
mg/kg or cis-atracurium 0.15 mg/kg. Face mask ventilation will be quantified as grade 0-4.
Anesthesia maintenance will be intravenous or inhalatory depending on anesthesiologists
decision. Patients will be intubated with Macintosh blade in the supine position, without
additional elevation of occipital part of the head. Difficult laryngoscopy is defined as CL
grade III and IV and they predict difficult endotracheal intubation. Intubation difficulty
score will be used to asses intubation. Intubation difficulty will be defined by IDS -
intubation difficulty score > 5.
Standard procedures will be performed in case of difficult mask ventilation and intubation.