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NCT Number: NCT07423741

Ultrasonographical Assessment of Airway Indices in Pregnancy

Clinical and ultrasound indices of airway, in addition to laryngoscopic view will be assessed and compared among three groups of patients: non pregnant, pregnant with normal blood pressure, preeclampsia patients undergoing various surgeries under general anesthesia.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Qena University

Qina, Qena Governorate, 83511, Egypt

Location status: Recruiting

Location contact

ZAINAB MOSTAFA

CONTACT

[email protected]

01009071365

About this study

Tracheal intubation (TI) through direct laryngoscopy is often performed in patients to establish an airway to provide adequate ventilation and oxygenation, and/or to protect the airway from aspiration of oral and pharyngeal secretions. Difficult intubation occurs due to insufficient vision of the larynx during direct laryngoscopy. Some constraints such as full stomach and aspiration risk, unknown past medical and allergy history may make the actual number of difficult intubation in operating room. It seems that, to prevent complications due to repeated attempt for intubation (arrythmia, hypoxia, …), early detection of probable difficult laryngoscopy cases is of great importance in the operating room. Therefore, various screening methods and scales have been defined in this regard . Cormack-Lehane classification and Mallampati are among screening methods that is used to predict difficult airway and laryngoscopy cases; However, all have considerable limitations . Therefore, the search for a simple, non-invasive technique that provides a more accurate assessment of the patient's airway still continues. The ideal method is expected to be fast, accessible, simple and non-invasive .Today, portable ultrasound devices are widely available in OR and recently studies have focused on its capabilities in terms of airway management . At present, airway ultrasonography is not yet used as a common method for airway assessment. Although several parameters of airway ultrasound have been mentioned in various studies as difficult airway prediction indicators, research is still ongoing to obtain easy and accurate measures . Therefore, this study performed to investigate the relationship between some upper airway ultrasound assessment parameters with difficult laryngoscopy / difficult intubation in pregnant and preeclamptic females and aim to use these parameters to assist physician to decide about difficult laryngoscopy/ difficult intubation and consider as predictors beside the traditional methods.

The first step in airway management is the assessment of various airway indices. Various anatomical and physiological factors place pregnant females at greater risk of airway management complications and difficult intubation. Hypertensive conditions of pregnancy are associated with aggravated changes in the airway, including a narrower upper airway compared with healthy pregnant females. In routine clinical practice, quick and easy bedside assessments are performed pre-operatively to evaluate the airway. These methods have high interobserver variability and only fair to moderate sensitivity and specificity. The role of ultrasound in airway assessment is encouraging as anatomical structures can be visualised in supraglottic, glottis and subglottic views. With the development of better probes, high resolution imaging, real-time pictures and clinical experience, In this prospective study, we assessed the airway indices of non-pregnant, normotensive pregnant and preeclamptic pregnant females using both clinical parameters and ultrasonographic assessment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • -normotensive pregnant
  • pre-eclamptic patients.
  • nonpregnant females in child bearing period .

Exclusion criteria

  • Patients excluded were women at <32 weeks' gestation or with Eclampsia .
  • height <150 cm, body mass index (BMI) >30 kg/m2 .
  • predicted airwy difficulty due to any other cause as neck swelling , facial deformity and prominent teeth.

Treatment and study plan

Primary outcomes

  1. Sperficial ultrasonographic airway assessemt

    Time frame: preoperative just before induction of anesthesia

    By using superficial ultrasound probe, we measure in millimeters: anterior neck skin to hyoid bone distance, anterior neck skin to vocal cord distance (ANS-VC) ,distance from the epiglottis to the midpoint of the distance between the vocal cords (E-VC),the depth of pre-epiglottic space (Pre-E) and Pre-E/E-VC ratio). All parameters will be measured in millimeters in all groups by the same doctor, and the same ultrasound device.

Secondary outcomes

  1. Assessment of laryngoscopic view

    Time frame: preoperative just before endotracheal intubation

    In all groups, we assess laryngoscopic view of airway using Cormack-Lehane classification system. Grade 1: Full view of the glottis (entire vocal cords and anterior commissure visible); intubation is straightforward. Grade 2: Partial glottic view; subdivided into 2a (posterior vocal cords visible) and 2b (only arytenoids seen); intubation often possible with manipulation. Grade 3: Only epiglottis visible, no glottis; intubation typically requires advanced techniques. Grade 4: Epiglottis not visible; predicts failed intubation, needing alternatives.

  2. Tongue thickness

    Time frame: Once just before induction of general anesthesia

    By using deep ultrasound probe, we measure tongue thickness

  3. Hyoid bone visibility

    Time frame: Preoperative just before induction of anesthesia

    By using deep ultrasound probe, we measure hyoid bone visibility(HBV)

Study contacts

Contact information is provided by the study sponsor or research team.

Zeinab M Sayed, MD

CONTACT

[email protected]

01009071365 ext. +02

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

Clinical and Ultrasonographic Assessment of Airway Indices Among Nonpregnant, Normotensive Pregnant and Pre-eclamptic Patients: a Prospective Observational Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

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

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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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