Ultrasonographic Parameters in Prediction of Difficult Laryngoscopy in Non-suspected Difficult Airway Patients

NCT06052189 | Completed

• 1 other identifier: 35566/6/22
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the ultrasonographic parameters (distance from skin to epiglottis (DSE) and distance from skin to vocal cords (DSVC)) as preoperative predictors of difficult laryngoscopy in non-suspected difficult airway patients undergoing elective surgery.

Conditions

Ultrasound; Difficult Laryngoscopy; Prediction

Outcome Measures

Primary Outcomes (1)

• Correlation between the ultrasonographic parameters and the modified Cormack and Lehane grading scale

  Correlation between the ultrasonographic parameters (distance from skin to epiglottis ( DSE) and distance from skin to vocal cords (DSVC)) and the modified Cormack and Lehane grading scale of laryngoscopy as easy or difficult

  10 minutes during intubation.

Secondary Outcomes (4)

• Sensitivity of ultrasonographic distance from skin to epiglottis to predict difficult laryngoscopy.

  10 minutes during intubation.

• Sensitivity of ultrasonographic distance from skin to vocal cords to easy laryngoscopy.

  10 minutes during intubation.

• Specificity of ultrasonographic distance from skin to epiglottis to predict difficult laryngoscopy.

  10 minutes during intubation.

• Specificity of ultrasonographic distance from skin to vocal cords to easy laryngoscopy.

  10 minutes during intubation.

Study Arms (2)

Easy laryngoscopy

Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy.

Procedure: Ultrasound

Difficult laryngoscopy

Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy.

Procedure: Ultrasound

Interventions

Ultrasound PROCEDURE

Ultrasonographic parameters: in the parasagittal plane (1cm from midline) with the patient lying supine, without a pillow, head, and neck in the neutral position, looking straight ahead with mouth closed and the tongue on the floor of the mouth without any movement.

Difficult laryngoscopy; Easy laryngoscopy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective observational study will be carried out on 85 patients at Tanta University Hospital in the anesthesia department over a period of one year from May 2022 to May 2023, which may be extended after approval from the institutional ethical committee of the faculty of medicine at Tanta University. Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy.

You may qualify if:

• Aged 18 - 65 years.
• Both sexes.
• Patients who aren't suspected to have a difficult airway after preoperative airway assessment by conventional clinical tests such as modified Mallampati classification (MMC), thyromental distance (TMD), inter-incisor distance (IID), cervical mobility (CM), And neck circumference (NC).
• American society of anesthesia (ASA) I, II, and III physical status.
• Scheduled for elective surgery under general anaethesia.

You may not qualify if:

• Patients with maxillofacial injury and airway trauma.
• Patients with a history of previous difficult intubation.
• Patients with anatomical abnormalities.
• Neck scarring, swelling, or burn.
• Pregnancy.
• Obesity.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical ICU, and Pain therapy

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of the study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)