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Completed

NCT Number: NCT06052189

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Correlation between the ultrasonographic parameters and the modified Cormack and Lehane grading scale

    Time frame: 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 outcomes

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Use of Ultrasonographic Parameters in Preoperative Prediction of Difficult Laryngoscopy in Non-suspected Difficult Airway Patients Undergoing Elective Surgery; a Prospective Observational Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2023
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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