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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03920748
Other study ID # 2018105
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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 )

Study Design


Related Conditions & MeSH terms


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
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