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

Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03920748
• Other study ID #: 2018105
• Status: Completed
• Start date: July 10, 2018
• Est. completion date: July 10, 2019

Study information

• Verified date: January 2020
• Source: Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 10, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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 )

Related Conditions & MeSH terms

• Anesthesia Intubation Complication
• Infant
• Newborn

Intervention

Other:
• Group D
According to Cormack-Lehane (CL) Classification; laryngoscopic view grade 3-4 is defined as Group D
• Group E
According to Cormack-Lehane (CL) Classification; laryngoscopic view grade 1-2 is defined as Group E

Locations

Country	Name	City	State
Turkey	Ankara Childrens' Health and Diseases Hematology Oncology Training and Research Hospital	Ankara

Sponsors (1)

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

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thyromental distance (TMD)	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.	1 hour
Primary	Other airway measurements	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.	1 hour
Secondary	Demographic data	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.	1 hour