Skip to main content
OpenTrials
Completed

NCT Number: NCT03920748

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Childrens' Health and Diseases Hematology Oncology Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Group D

Other

According to Cormack-Lehane (CL) Classification; laryngoscopic view grade 3-4 is defined as Group D

Group E

Other

According to Cormack-Lehane (CL) Classification; laryngoscopic view grade 1-2 is defined as Group E

Primary outcomes

  1. Thyromental distance (TMD)

    Time frame: 1 hour

    The thyromental distance, unit of measure cm, is detected using a US linear probe with the transducer placed in the transverse plane. Thyromental distance is measured in cm as straight line from thyroid notch to lower border of mentum with head extended in all patients.

  2. Other airway measurements

    Time frame: 1 hour

    The other primary objective of this study is to identify if any preanesthetic airway assessment maneuvers (such as 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) would be associated with difficult laryngoscopy in newborn and infants.

Secondary outcomes

  1. Demographic data

    Time frame: 1 hour

    The secondary objective of this study is to identify if factors such as age, sex, bady mass index (BMI) and physical status grade would be associated with grade III and IV laryngoscope views in newborn and infants.

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2019
Registry last updated
Jan 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.