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

NCT03920748 | Completed

• 1 other identifier: 2018105
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Intubation Complication; Infant; Newborn

Keywords

Difficult laryngoscopy, airway measurements, newborn, infant

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Demographic data

  1 hour

Study Arms (2)

Difficult laryngoscopy (Group D)

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).

Other: Group D

Easy laryngoscopy (Group E)

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).

Other: Group E

Interventions

Group D OTHER

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

Difficult laryngoscopy (Group D)

Group E OTHER

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

Easy laryngoscopy (Group E)

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

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

Ankara, 06110, Turkey (Türkiye)

Location

Study Officials

• Feyza Sever

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist physician

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: July 10, 2018
• Primary Completion: July 10, 2019
• Study Completion: July 10, 2019
• Last Updated: January 10, 2020

Record last verified: 2020-01

Locations

TU (1)