Clinical trial NCT03920748: Evaluation of the Relationship Between Airway Measurements and Laryngoscopic View in Newborn and Infants
Official title: Evaluation of the Relationship Between Airway Measurements With Ultrasonography and Laryngoscopic View in Newborn and Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Intubation Complication
Infant
Newborn
Keywords: Difficult laryngoscopy, airway measurements, newborn, infant
Lead sponsor: Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-04-19
Enrollment: 150
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn and infant age group undergoing elective surgery at Ankara Childrens' Health and Diseases Hematology Oncology Training and Research Hospital

Brief summary: Background and Aim: The overall incidence of difficult laryngoscopy in pediatric anesthesia is lower than in adults, but this risk is higher in patients younger than one year of age. In the last decade, different measurements have been used to obtain difficult laryngoscopy markers in children. In this study, we aimed to evaluate the relationship between the airway measurements (some performed by using ultrasonography (USG)) and the difficult laryngoscopic view in neonates and infants.

Design: This is a prospective, single blinded, observational study. The number of patients was calculated as follows: A sample of 12 from the positive group (difficult laryngoscopy group) and 96 from the negative group (easy laryngoscopy group) achieve 80% power to detect a difference of 0.25 between the area under the ROC curve (AUC) under the null hypothesis of 0.50 and an AUC under the alternative hypothesis of 0,75 using a two-sided z-test at a significance level of 0.05.

Methods: All patients which is newborn and infant age group undergoing elective surgery requiring intubation under general anesthesia are assessed. Patients' age, body mass index (BMI), thyromental distance, mandibula length, the distance between the lip corner and ipsilateral ear tragus, and the transverse length (measured by hand sign-middle-ring fingers adjacent side by side) measurements are recorded. In thyromental distance measurement, "thyroid notch" are determined by USG.

The laryngoscopic view is graded by a different experienced anaesthetist who is blinded to the airway measurements.

Statistical analysis:

Receiver operating characteristic (ROC) curves are used to determine the best cut-off point for distance variables in the separation of difficult and easy laryngoscopy groups. Sensitivity, selectivity, positive predictive value and negative predictive values of lengths are calculated according to determined cut point.The difference between the two groups in terms of qualitative variables are evaluated by chi-square or Fisher's exact test. The normal distribution of the numerical variables are examined with the Shapiro-Wilk test. The difference between the two groups in terms of numerical variables are investigated by Mann Whitney U test. Values of p \<0.05 are considered as statistically significant.


Eligibility criteria: Inclusion Criteria:

* Newborn and infant age group
* Undergoing elective surgery requiring intubation under general anesthesia

Exclusion Criteria:

* History of congenital maxillofacial defect,
* History of upper airway pathology (tumor, cleft palate-lips, etc.)
* History of head and neck trauma (fracture, swelling, scar )

Primary outcomes:
measure: Thyromental distance (TMD)
timeFrame: 1 hour
measure: Other airway measurements
timeFrame: 1 hour
Secondary outcomes:
measure: Demographic data
timeFrame: 1 hour
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Childrens' Health and Diseases Hematology Oncology Training and Research Hospital
Study officials:
affiliation: Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
name: Feyza Sever
role: PRINCIPAL_INVESTIGATOR
References: