NCT07057661

Brief Summary

An unexpected difficult airway can lead to severe hypoxia and even death. Accurate airway assessment can reduce the incidence of difficult endotracheal intubation and related complications. Studies have shown that some ultrasonic indicators can predict difficult airways in adults to some extent. Studies have begun to investigate whether ultrasonic parameters can be used to predict difficult airways in children.Ultrasonic measurements of certain airway parameters have predictive value for difficult airways; therefore, airway ultrasonography is recommended as an aid in difficult airway prediction. We think that in pediatric patients with adenotonsillectomy, we will encounter more difficult airway because there may be anatomical differentiation due to adenoid and tonsillar hypertrophy. We aimed to evaluate the frequency of difficult airway with USG measurements in pediatric patients undergoing adenotonsillectomy. Group 1:Pediatric patients who underwent adenotonsillectomy Group 2: Pediatric patients who underwent any surgical operation We will evaluate two patient groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 30, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

August 20, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

June 8, 2025

Last Update Submit

August 18, 2025

Conditions

Keywords

airway managementpediatric patientsultrasonography

Outcome Measures

Primary Outcomes (3)

  • DSE: Distance from skin to epiglottis

    the vertical distances from the submental skin to the midpoint of the epiglottis

    Preoperative , before the administration of anesthesia

  • HMDE: Hyomental distance in the extended position

    the distance from the lower border of the mentum of the mandible to the upper border of the hyoid bone

    Preoperative , before the administration of anesthesia

  • Tongue base thickness

    Preoperative , before the administration of anesthesia

Secondary Outcomes (1)

  • Cormark Lehane score

    During laryngoscopy

Study Arms (2)

Group 1: Pediatric patients who underwent adenotonsillectomy

Group 2: Pediatric patients who underwent any surgical operation

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Pediatric patients who underwent adenotonsillectomy and any surgical operation

You may qualify if:

  • ASA 1-2 patients
  • Pediatric patients aged 3-8
  • Those planned for elective surgery

You may not qualify if:

  • Those with a history of congenital anomalies (head, face, body)
  • ASA 3-4-5 patients
  • Those who will undergo emergency surgery
  • Those who will be subjected to an airway or anesthesia technique other than orotracheal intubation
  • Newborn group patients
  • Patients younger than 3 years old and older than 8 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir City Hospital

Izmir, Bayraklı, Turkey (Türkiye)

Location

Study Officials

  • Tuba Kuvvet Yoldas, MD, Anesthesiology Specialist

    Izmir City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuba Kuvvet Yoldas, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Anesthesia Specialist

Study Record Dates

First Submitted

June 8, 2025

First Posted

July 10, 2025

Study Start

August 30, 2025

Primary Completion

October 30, 2025

Study Completion

November 30, 2025

Last Updated

August 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations