Enhancing Difficult Laryngoscopy Prediction Through A Mixed Scoring System

NCT06815952 | Recruiting

• 1 other identifier: BIO-2024-0255
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop a comprehensive airway assessment score including traditional bedside clinical tests and ultrasound measurements with high accuracy in predicting difficult airway, and to validate it through testing it on a large population sample. The main question it aims to answer is: Is the comprehensive scoring system that includes clinical bedside and ultrasound measurements developed to predict difficult airways valid in a large population sample? Adult patients undergoing general anesthesia with American Society of Anesthesiologists (ASA) classification 1-4 will be recruited. Traditional and ultrasound measurements will be collected.

Conditions

Intubation; Laryngoscopy; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Number of patients with difficult laryngoscopy

  Intubation requiring up to three attempts, an intubation time of more than 10 min, a Cormack Lehane score more than or equal to 3, or the use of a bougie, stylet or a videolaryngoscope

  20 minutes following the scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing general anesthesia, American Society of Anesthesiologists (ASA) classification, emergency or elective cases.

You may qualify if:

• Adult patients undergoing general anesthesia
• American Society of Anesthesiologists (ASA) classification 1-4
• Emergency or elective cases

You may not qualify if:

• Patients with confirmed history of difficult airway
• Patients with maxillofacial trauma or cervical spine injury or instability
• Pregnant patients
• Patients with a history of head and neck cancer
• Patients with known subglottic stenosis
• Patients requiring a double lumen tube insertion
• Patients with a history of neck radiotherapy

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

RECRUITING

Study Officials

• Nancy Abou Nafeh, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Abou Nafeh, MD

CONTACT

01350000; na181@aub.edu.lb

Thouraya HajAli

CONTACT

01350000; th64@aub.edu.lb

Study Design

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

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 10, 2025
• Study Start: February 20, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)