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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-10

Study Completion Date

2019-07-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Difficult Laryngoscopy With Ultrasonography in Pediatric Patients

NCT05833347

Intubation; Difficult or Failed Difficult Laryngoscopy

COMPLETED

The Effects of Different Airway Devices on Middle Ear Pressure in Pediatric Patients

NCT02334072

Local Pressure Effects Simple Ear

UNKNOWN NA

Laryngeal Mask Airway Failure in Pediatric Patients

NCT06337006

Airway Management

COMPLETED

Videolaryngoscopy at Unanticipated Difficult Airway

NCT06972394

Difficult Airway Videolaryngoscopy

COMPLETED

Indirect Laryngoscopy and Ultrasonography in Prediction of Difficult Airway

NCT04226703

Difficult Intubation

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia Intubation Complication Infant Newborn

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group D

Intervention Type OTHER

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

Group E

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Group D

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

Intervention Type OTHER

Group E

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 )

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes