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

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT06052189
Collaborator
(none)
85
1
12
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ultrasound

Detailed Description

Airway management is an integral part of general anesthesia. It simply aims to secure the patient's airway and achieve adequate ventilation and oxygenation for the patient undergoing surgery under general anesthesia. Unsuccessful airway management due to the unexpected difficulty in laryngoscopy is a life-threatening situation and may lead to morbidity and mortality.

Many conventional clinical tests are used in preoperative airway assessment such as modified Mallampati classification, Thyro-mental distance, inter-incisor distance, cervical mobility, and neck circumference, which are used to predict difficulty in the airway, but they have limited value and low sensitivity and specificity. Difficult laryngoscopy cannot be always predicted based on the preoperative assessment by conventional clinical tests. Some patients are thought to have an easy airway by clinical tests, but they show an unexpected difficulty in the laryngoscopy.

The laryngeal view of the patient can be assessed and graded during direct laryngoscopy using the Cormack and Lehane grading scale and its modification that describes the laryngoscopy as easy or difficult.

Ultrasonography is a valuable promising tool for preoperative airway evaluation through identifying important sonoanatomy of the upper airway such as epiglottis, thyroid cartilage, and vocal cords.

Study Design

Study Type:
Observational
Actual Enrollment :
85 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Use of Ultrasonographic Parameters in Preoperative Prediction of Difficult Laryngoscopy in Non-suspected Difficult Airway Patients Undergoing Elective Surgery; a Prospective Observational Study
Actual Study Start Date :
May 1, 2022
Actual Primary Completion Date :
May 1, 2023
Actual Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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

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
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.

Outcome Measures

Primary Outcome Measures

  1. Correlation between the ultrasonographic parameters and the modified Cormack and Lehane grading scale [10 minutes during intubation.]

    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

Secondary Outcome Measures

  1. Sensitivity of ultrasonographic distance from skin to epiglottis to predict difficult laryngoscopy. [10 minutes during intubation.]

    Measurement of Sensitivity of ultrasonographic distance from skin to epiglottis to predict 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.

  2. Sensitivity of ultrasonographic distance from skin to vocal cords to easy laryngoscopy. [10 minutes during intubation.]

    Measurement of Sensitivity of ultrasonographic distance from skin to epiglottis to predict 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.

  3. Specificity of ultrasonographic distance from skin to epiglottis to predict difficult laryngoscopy. [10 minutes during intubation.]

    Measurement of Specificity of ultrasonographic distance from skin to epiglottis to predict 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.

  4. Specificity of ultrasonographic distance from skin to vocal cords to easy laryngoscopy. [10 minutes during intubation.]

    Measurement of Specificity of ultrasonographic distance from skin to epiglottis to predict 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tanta University Tanta El-Gharbia Egypt 31527

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Salah Eldein Shalaby Abotaleb, Resident of Anesthesiology, Surgical ICU, and Pain therapy, Tanta University
ClinicalTrials.gov Identifier:
NCT06052189
Other Study ID Numbers:
  • 35566/6/22
First Posted:
Sep 25, 2023
Last Update Posted:
Sep 25, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 25, 2023