Evaluation of the Relationship Between Airway Measurements and Laryngoscopic View in Newborn and Infants

Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital

Status: Completed

Conditions: Anesthesia Intubation Complication; Newborn; Infant

Treatments: Other: Group D; Other: Group E

Study type: Observational

Funder types: Other

Identifiers

NCT03920748

2018105

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: Under 24 months old

Volunteers: Accepts Healthy Volunteers

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 )

Trial design

150 participants in 2 patient groups

Difficult laryngoscopy (Group D)

Description:

Glottic structures appearing during laryngoscopy are graded according to Cormack-Lehane (CL) Classification. According to this classification, patients are divided into two groups, patients with grade 3-4 are classified as difficult laryngoscopy ( Group D).

Treatment:

Other: Group D

Easy laryngoscopy (Group E)

Description:

Glottic structures appearing during laryngoscopy are graded according to Cormack-Lehane (CL) Classification. According to this classification, patients are divided into two groups, patients with grade 1-2 are classified as easy laryngoscopy ( Group E).

Treatment:

Other: Group E