- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07423741
Ultrasonographical Assessment of Airway Indices in Pregnancy
Clinical and Ultrasonographic Assessment of Airway Indices Among Nonpregnant, Normotensive Pregnant and Pre-eclamptic Patients: a Prospective Observational Study
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Zeinab M Sayed, MD
- Phone Number: +02 01009071365
- Email: zeinab5aton@gmail.com
Study Locations
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Qena Governorate
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Qina, Qena Governorate, Egypt, 83511
- Recruiting
- Qena University
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Contact:
- ZAINAB MOSTAFA
- Phone Number: 01009071365
- Email: zeinab5aton@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Non Pregnant
non pregnant patients undergoing surgery under general anesthesia
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pregnant normotensive
pregnant normotensive patients undergoing surgery under general anesthesia
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preeclampsia
preeclampsia patients undergoing surgery under general anesthesia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sperficial ultrasonographic airway assessemt
Time Frame: preoperative just before induction of anesthesia
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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.
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preoperative just before induction of anesthesia
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of laryngoscopic view
Time Frame: preoperative just before endotracheal intubation
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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.
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preoperative just before endotracheal intubation
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Tongue thickness
Time Frame: Once just before induction of general anesthesia
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By using deep ultrasound probe, we measure tongue thickness
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Once just before induction of general anesthesia
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Hyoid bone visibility
Time Frame: Preoperative just before induction of anesthesia
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By using deep ultrasound probe, we measure hyoid bone visibility(HBV)
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Preoperative just before induction of anesthesia
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ِAIP028-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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