Airway AssessmentNCT07423741
Ultrasonographical Assessment of Airway Indices in Pregnancy
An observational study of Airway Assessment, run by South Valley University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Airway Assessment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: non pregnant, normotensive pregnant and preeclamptic patients who are undergoing general anesthesia, and also apply to the inclusion criteria and have non of the exclusion criteria mentioned above.
Who may be able to join
- -normotensive pregnant
- pre-eclamptic patients.
- nonpregnant females in child bearing period .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Qena University
Qina, Qena Governorate, 83511
ZAINAB MOSTAFA, 01009071365, zeinab5aton@gmail.com
About this study
Official title: Clinical and Ultrasonographic Assessment of Airway Indices Among Nonpregnant, Normotensive Pregnant and Pre-eclamptic Patients: a Prospective Observational Study
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.
Read the 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.
- Conditions
- Airway Assessment
- Keywords
- airway, ultrasound, preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non Pregnant | non pregnant patients undergoing surgery under general anesthesia | |
| pregnant normotensive | pregnant normotensive patients undergoing surgery under general anesthesia | |
| preeclampsia | preeclampsia patients undergoing surgery under general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperficial ultrasonographic airway assessemt
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.
Measured: preoperative just before induction of anesthesia
Secondary outcomes (3)
Assessment of laryngoscopic view
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.
Measured: preoperative just before endotracheal intubation
Tongue thickness
By using deep ultrasound probe, we measure tongue thickness
Measured: Once just before induction of general anesthesia
Hyoid bone visibility
By using deep ultrasound probe, we measure hyoid bone visibility(HBV)
Measured: Preoperative just before induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start15 Dec 2024
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gaber Ahmed, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423741
- Sponsor's protocol ID
- ِAIP028-3
- Status last verified
- Feb 2026
- First submitted
- 25 Nov 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Ultrasonographic Assessment of Airway Indices Among Nonpregnant, Normotensive Pregnant and Pre-eclamptic Patients: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07423741
- Acronym / sponsor ID
- ِAIP028-3
- Conditions
- Airway Assessment
- Keywords
- airway, ultrasound, preeclampsia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non Pregnant | – | –non pregnant patients undergoing surgery under general anesthesia |
| pregnant normotensive | – | –pregnant normotensive patients undergoing surgery under general anesthesia |
| preeclampsia | – | –preeclampsia patients undergoing surgery under general anesthesia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- non pregnant, normotensive pregnant and preeclamptic patients who are undergoing general anesthesia, and also apply to the inclusion criteria and have non of the exclusion criteria mentioned above.
Key inclusion criteria (3 listed)
- -normotensive pregnant
- pre-eclamptic patients.
- nonpregnant females in child bearing period .
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Assessment of laryngoscopic view
Time frame: preoperative just before endotracheal intubation
Tongue thickness
Time frame: Once just before induction of general anesthesia
Hyoid bone visibility
Time frame: Preoperative just before induction of anesthesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Assessment, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeinab M Sayed, MD (01009071365 ext. +02, zeinab5aton@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperficial ultrasonographic airway assessemt (time frame: preoperative just before induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.