Critical IllnessNCT06651879
Ultrasound Airway Assessment of Critically Ill Preeclamptic; Comparison Between Two Technique
A study testing techniques of ultrasound examination of the airway in people with Critical Illness and Difficult; Intubation, Postpartum, During Puerperium, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Critical Illness, Difficult; Intubation, Postpartum, During Puerperium, Pre-Eclampsia
- What is being tested?
- techniques of ultrasound examination of the airway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2024to 1 Dec 2025
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
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
Ain shams university
Cairo, Cairo Governorate, 11528
Anesthesia department, 01009499962, anesth_office@med.asu.edu.eg
About this study
Official title: the Preoperative Use of Ultrasound in Airway Assessment in Critically Ill Obstetrics With Pre-eclampsia; Comparison Between Two Ultrasound Techniques in Relation to the Standard Clinical Assessment
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.
Read the detailed 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.
- Being tested
- techniques of ultrasound examination of the airway
- Medical subject headings
- Critical Illness, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
techniques of ultrasound examination of the airwayDiagnostic test
two different techniques of ultrasound. The techniques are the two views and the five views
| Study group | Role | What they receive |
|---|---|---|
| Two views ultrasound technique | Experimental | : the ultrasound examiner will use the difficult airway examination by sonography (DARES) protocol in which involves only two views of the upper airway: the thyrohyoid and the suprahyoid views. Measurements selected for this protocol include the DSE, HMD, HMDR1, HMDR2, and tongue thickness, which cover all three domains of TTD, APD, and OSD Receives: Diagnostic Test: techniques of ultrasound examination of the airway |
| Five views ultrasound technique | Active comparator | The thicknesses of the anterior neck soft tissues will be measured by systematic examination includes five views: 1) Suprahyoid View .2) Thyrohyoid view; will be used to visualize epiglottis and pre -epiglottic space(PES).3) Thyroid view; for vocal cord visualization.4) Cricothyroid view .5) Suprasternal view From the previous views the following will be measured: tongue volume (TV ) ANS-H: anterior neck skin thickness at hyoid; TMD: thyromental distance; ANS-E: anterior neck skin thickness at epiglottis; ANS-VC: anterior neck skin thickness at vocal cords; SD: subglottic diameter PreE: pre epiglottic space; aVF: anterior vocal folds; pVF: posterior vocal folds; mVF: midpoint of anterior , posterior vocal folds , and diameter of the transverse tracheal air shadow in the subglottic area . The following will be calculated PreE/aVF, PreE/mVF , PreE/pVF and PreE/E-VC. That will be in addition to detection of any abnormalities in the airway Receives: Diagnostic Test: techniques of ultrasound examination of the airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
The predictivity of both us techniques in relation to clinical assessment of El-Ganzouri index (EGRI).
Sensitivity and specificity of the measured parameters in both ultrasound techniques in relation to the clinical El-ganzouri score where (score < 4 is unlikely to be difficult and score ≥ 4 is more likely to be difficult) to predict difficult airway.
Measured: the degree of difficult intubation will be assesed intraoperative after aneesthesia and intubation, clinical assessment will be preoperative, the us assessment will be preoperative at the same day of operation or immediately postoperative
The predictive superiority between 2 view and 5 views ultrasound techniques regarding difficult ventilation, laryngoscopy and intubation
- Difficult ventilation is measured by Hans score where grade 0 and 1 will be categorized as easy ventilation, while <= 2 are difficult
- Difficult intubation is measured by Cormack-Lehane grade where where grade 1 nad 2a will be categorized as easy while <= 2b will be categorized as difficult.
- Prolonged intubation <10 min or repeated attempts < 3 will be categorized as difficult.
Measured: the actual degree of difficult intubation will be assesed intraoperative after aneesthesia and intubation, the us assessment will be done preoperative at the same day of operation or immediately postoperative
Secondary outcomes (2)
postoperative side effects
Any postoperative adverse effects as patient discomfort from airway, mandibular pain or stridor
Measured: within 24 hours postoperative
duration of the airway assessment
time needed for ultrasound evaluation measured from the start of the technique till the end of the ultrasound examination, and duration of the clinical EL-Ganzouri assessment
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start20 Jul 2024
- Primary completion20 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial is a pilot of randomized clinical, two parallel groups, 1:1 allocation, superiority study.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651879
- Sponsor's protocol ID
- FMASU R147/2024
- Status last verified
- Jan 2025
- First submitted
- 2 Aug 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bala R, Budhwar D, Kumar V, Singhal S, Kaushik P, Sharma J. Clinical and ultrasonographic assessment of airway indices among non-pregnant, normotensive pregnant and pre-eclamptic patients: a prospective observational study. Int J Obstet Anesth. 2023 May;54:103637. doi: 10.1016/j.ijoa.2023.103637. Epub 2023 Feb 1.
PubMed 36827944Gomes SH, Simoes AM, Nunes AM, Pereira MV, Teoh WH, Costa PS, Kristensen MS, Teixeira PM, Pego JM. Useful Ultrasonographic Parameters to Predict Difficult Laryngoscopy and Difficult Tracheal Intubation-A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2021 May 28;8:671658. doi: 10.3389/fmed.2021.671658. eCollection 2021.
PubMed 34124099Zheng BX, Zheng H, Lin XM. Ultrasound for predicting difficult airway in obstetric anesthesia: Protocol and methods for a prospective observational clinical study. Medicine (Baltimore). 2019 Nov;98(46):e17846. doi: 10.1097/MD.0000000000017846.
PubMed 31725624Izci B, Riha RL, Martin SE, Vennelle M, Liston WA, Dundas KC, Calder AA, Douglas NJ. The upper airway in pregnancy and pre-eclampsia. Am J Respir Crit Care Med. 2003 Jan 15;167(2):137-40. doi: 10.1164/rccm.200206-590OC. Epub 2002 Oct 31.
PubMed 12411285
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Preoperative Use of Ultrasound in Airway Assessment in Critically Ill Obstetrics With Pre-eclampsia; Comparison Between Two Ultrasound Techniques in Relation to the Standard Clinical Assessment
- ClinicalTrials.gov ID
- NCT06651879
- Acronym / sponsor ID
- FMASU R147/2024
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 Oct 2024 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- The trial is a pilot of randomized clinical, two parallel groups, 1:1 allocation, superiority study.
| Arm | Type | Receives |
|---|---|---|
| Two views ultrasound technique | Experimental | Diagnostic Test: techniques of ultrasound examination of the airway: the ultrasound examiner will use the difficult airway examination by sonography (DARES) protocol in which involves only two views of the upper airway: the thyrohyoid and the suprahyoid views. Measurements selected for this protocol include the DSE, HMD, HMDR1, HMDR2, and tongue thickness, which cover all three domains of TTD, APD, and OSD |
| Five views ultrasound technique | Active comparator | Diagnostic Test: techniques of ultrasound examination of the airwayThe thicknesses of the anterior neck soft tissues will be measured by systematic examination includes five views: 1) Suprahyoid View .2) Thyrohyoid view; will be used to visualize epiglottis and pre -epiglottic space(PES).3) Thyroid view; for vocal cord visualization.4) Cricothyroid view .5) Suprasternal view From the previous views the following will be measured: tongue volume (TV ) ANS-H: anterior neck skin thickness at hyoid; TMD: thyromental distance; ANS-E: anterior neck skin thickness at epiglottis; ANS-VC: anterior neck skin thickness at vocal cords; SD: subglottic diameter PreE: pre epiglottic space; aVF: anterior vocal folds; pVF: posterior vocal folds; mVF: midpoint of anterior , posterior vocal folds , and diameter of the transverse tracheal air shadow in the subglottic area . The following will be calculated PreE/aVF, PreE/mVF , PreE/pVF and PreE/E-VC. That will be in addition to detection of any abnormalities in the airway |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Patient's Refusal to participate,
- Abnormal pharynx or airway anatomy,
- expected difficult laryngoscopy with cervical spine abnormality,
- Maxillofacial anomalies,
- upper airway diseases or malignancy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| techniques of ultrasound examination of the airwaytwo different techniques of ultrasound. The techniques are the two views and the five views | Diagnostic test | Five views ultrasound technique, Two views ultrasound technique |
Primary outcome
The predictivity of both us techniques in relation to clinical assessment of El-Ganzouri index (EGRI).
Time frame: the degree of difficult intubation will be assesed intraoperative after aneesthesia and intubation, clinical assessment will be preoperative, the us assessment will be preoperative at the same day of operation or immediately postoperative
Sensitivity and specificity of the measured parameters in both ultrasound techniques in relation to the clinical El-ganzouri score where (score < 4 is unlikely to be difficult and score ≥ 4 is more likely to be difficult) to predict difficult airway.
The predictive superiority between 2 view and 5 views ultrasound techniques regarding difficult ventilation, laryngoscopy and intubation
Time frame: the actual degree of difficult intubation will be assesed intraoperative after aneesthesia and intubation, the us assessment will be done preoperative at the same day of operation or immediately postoperative
* Difficult ventilation is measured by Hans score where grade 0 and 1 will be categorized as easy ventilation, while <= 2 are difficult * Difficult intubation is measured by Cormack-Lehane grade where where grade 1 nad 2a will be categorized as easy while <= 2b will be categorized as difficult. * Prolonged intubation <10 min or repeated attempts < 3 will be categorized as difficult.
2 secondary outcomes
postoperative side effects
Time frame: within 24 hours postoperative
duration of the airway assessment
Time frame: preoperative
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 18 Feb 2025.
- Background: PubMed 36827944Bala R, Budhwar D, Kumar V, Singhal S, Kaushik P, Sharma J. Clinical and ultrasonographic assessment of airway indices among non-pregnant, normotensive pregnant and pre-eclamptic patients: a prospective observational study. Int J Obstet Anesth. 2023 May;54:103637. doi: 10.1016/j.ijoa.2023.103637. Epub 2023 Feb 1.
- Results publication: PubMed 34124099Gomes SH, Simoes AM, Nunes AM, Pereira MV, Teoh WH, Costa PS, Kristensen MS, Teixeira PM, Pego JM. Useful Ultrasonographic Parameters to Predict Difficult Laryngoscopy and Difficult Tracheal Intubation-A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2021 May 28;8:671658. doi: 10.3389/fmed.2021.671658. eCollection 2021.
- Results publication: PubMed 31725624Zheng BX, Zheng H, Lin XM. Ultrasound for predicting difficult airway in obstetric anesthesia: Protocol and methods for a prospective observational clinical study. Medicine (Baltimore). 2019 Nov;98(46):e17846. doi: 10.1097/MD.0000000000017846.
- Results publication: PubMed 12411285Izci B, Riha RL, Martin SE, Vennelle M, Liston WA, Dundas KC, Calder AA, Douglas NJ. The upper airway in pregnancy and pre-eclampsia. Am J Respir Crit Care Med. 2003 Jan 15;167(2):137-40. doi: 10.1164/rccm.200206-590OC. Epub 2002 Oct 31.
- Individual participant dataSharing planned: Undecided
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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?
A study testing techniques of ultrasound examination of the airway in people with Critical Illness and Difficult; Intubation, Postpartum, During Puerperium, run by Ain Shams 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 0 inclusion and 7 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 18 Feb 2025. 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 wessam selima, MD (01001958858, w.z.selima@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The predictivity of both us techniques in relation to clinical assessment of El-Ganzouri index (EGRI). (time frame: the degree of difficult intubation will be assesed intraoperative after aneesthesia and intubation, clinical assessment will be preoperative, the us assessment will be preoperative at the same day of operation or immediately postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06651879, which also lists 4 linked publications.
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 18 Feb 2025.