Diagnostic Values of Physical Examination and Ultrasonographic Measurements in Predicting Difficult Airways

NCT06611917 | Completed

• 1 other identifier: COMU-SBF-AES-01
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness of ultrasonographic measurements compared to traditional physical examination tests in predicting difficult airways. With no definitive gold standard for anticipating airway challenges, this research explores the diagnostic capabilities of newer, non-invasive techniques like ultrasonography-which is gaining popularity due to its ease of use and widespread availability-in the field of anesthesia. The study focuses on defining highly sensitive and easy-to-use ultrasonographic markers that could aid anesthesiologists, intensive care specialists, and emergency physicians in effective airway management.

Conditions

Airway Complication of Anesthesia

Keywords

Airway Management; Endotracheal Intubation; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Difficult Airway Prediction

  The primary outcome measures the effectiveness of ultrasonography and physical examination in predicting difficult airways in patients undergoing general anesthesia. Occurrence of a difficult airway is the primary outcome. A difficult airway is defined by specific clinical criteria: More than two intubation attempts, Intubation time exceeding 10 minutes, or Cormack-Lehane laryngoscopy grade of 3 or 4. Data will be collected during the intubation process. Intubation attempts and time will be recorded by the anesthesiologist, while the Cormack-Lehane grading will be assessed based on the view of the glottis during laryngoscopy. Measurement Process: Ultrasonographic measurements of the airway will be taken preoperatively using non-invasive ultrasound techniques. Additionally, physical examination tests will be performed preoperatively to assess airway risk. The outcome is categorized as difficult airway (yes/no) based on whether the patient meets any of the defined criteria.

  up to one hour

Study Arms (1)

Ultrasonographic and Physical Examination Cohort

Participants in this study are patients scheduled for surgery under general anesthesia. The participants will undergo standard physical examination tests conducted by anesthesiologists before surgery and will also receive ultrasonographic measurements of the subglottic and other critical airway structures. The participants will be categorized as an observational cohort in which the ultrasonographic assessments will be compared with the results of the physical examination. The primary objective of this study is to compare the effectiveness of these two methods in predicting difficult airways.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients aged 18-60 years undergoing surgery under general anesthesia with an ASA classification of 1-3.

You may qualify if:

• Patients classified as American Society of Anesthesiologists (ASA) class I-II-III.
• Individuals aged between 18 and 60 years.
• Patients scheduled for elective surgery require endotracheal intubation under general anesthesia

You may not qualify if:

• Patients with pathologies in the airway or head and neck area (masses, cancer, congenital anomalies, acquired anatomical disorders).
• Individuals with active infections.
• Those with cervical vertebral damage.
• Patients with a history of head and neck trauma.
• Individuals who have undergone previous head and neck surgery.
• Patients with a history of head and neck radiotherapy.
• Pregnant individuals.
• Obese patients (body mass index \> 30).
• Non-cooperative patients.
• Patients are requiring surgery under emergency conditions.

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Canakkale Onsekiz Mart University

Çanakkale, Merkez, 17020, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Doctor

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: September 25, 2024
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)