Ultrasound Airway Assessment of Critically Ill Preeclamptic; Comparison Between Two Technique

Last updated: February 14, 2025
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Treatment

techniques of ultrasound examination of the airway

Clinical Study ID

NCT06651879
FMASU R147/2024
  • Female

Study Summary

Unexpected difficult airway exposes the patient to serious morbidity and even mortality. The changes in pregnancy and preeclampsia increase the risk of difficult intubation. Proper anticipation affects the outcome and enhances safety, especially in critically ill patients. This research aims to assess the superiority of either 2 views or 5 views ultrasound assessment in predictivity of difficult airway (difficult ventilation, laryngoscopy, and intubation) and their comparison to traditional clinical examination by El-Ganzouri Risk Index (EGRI) in critically ill obstetric patients with pre-eclampsia.

Eligibility Criteria

Inclusion

Inclusion Criteria:Critically ill preeclamptic patients for caesarean section under general anesthesia with the following criteria:

  • Aged from 18 to 60 years.

  • Singleton or multiple pregnancies,

  • Mentally competent.

  • American Society of Anesthesiologists (ASA) physical status I, II and III

Exclusion

Exclusion Criteria:

  • Patient's Refusal to participate,

  • Abnormal pharynx or airway anatomy,

  • expected difficult laryngoscopy with cervical spine abnormality,

  • Maxillofacial anomalies,

  • upper airway diseases or malignancy,

  • Unconscious women,

  • those with learning difficulties, or mentally handicapped

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: techniques of ultrasound examination of the airway
Phase:
Study Start date:
July 20, 2024
Estimated Completion Date:
December 01, 2025

Study Description

Unexpected difficult airway exposes the patient to serious morbidity and even mortality. Obstetrics airway carries the risk of complications due to physiological changes. The airway shows more restriction and changes in preeclamptic patients and peripartum periods. A study reported one incidence of difficult intubation in obstetrics in 20 cases. Inadequate airway management leads to failure in ventilation and oxygenation of the critically ill mother and her fetus.

the Practice Guidelines for Management of the Difficult Airway by the American Society of Anesthesiologists (ASA) define the difficult airway as difficult facemask ventilation of the upper airway, difficult tracheal intubation, or both. preoperative assessment of the airway avoids that risk; however, current clinical screening tests have low sensitivity and specificity with limited predictivity.

Ultrasound (US) provides a more precise assessment for tissues like epiglottis, vocal cords, and ring-shaped membranes; thus, it facilitates a bedside, non-invasive objective airway assessment. Moreover, ultrasound assessment can plan and guide airway interventions if needed. The airway in pregnancy goes through changes. a study concluded that The US airway assessment parameters differ significantly between pregnant and non-pregnant patients. Previous studies reported that the best predictors of difficult laryngoscopy and/or difficult intubation were the epiglottis midline-skin distance, hyoid bone-to-skin distance, thyroid cartilage-to-skin distance, thyrohyoid membrane-to-skin distance, and vocal cord anterior commissure-skin distance also predicted difficult airway. In Pregnancy, hyoid bone visibility, and Pre-E/E-VC ratio were independent predictors of the difficult airway.

Researchers suggested different techniques for airway ultrasound. Some suggested detailed technique that allows the determination of multiple parameters. Others suggested a more concise protocol to lessen the time of assessment and to avoid complexity.

This trial assesses the superiority of either 2 views or 5 views ultrasound assessment in predictivity of difficult airway (difficult ventilation, laryngoscopy, and intubation) and their comparison to traditional clinical examination by El-Ganzouri index (GREI) (9) in critically ill obstetric patients with pre-eclampsia.

Connect with a study center

  • Ain shams university

    Cairo, 11528
    Egypt

    Active - Recruiting

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