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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| techniques of ultrasound examination of the airway | Diagnostic Test | two different techniques of ultrasound. The techniques are the two views and the five views |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative side effects | Any postoperative adverse effects as patient discomfort from airway, mandibular pain or stridor | 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 |
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Inclusion Criteria:Critically ill preeclamptic patients for caesarean section under general anesthesia with the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wessam selima, MD | Contact | 01001958858 | w.z.selima@gmail.com | |
| ahmed moustafa, MD | Contact | 01121318459 | drahmed.mostafa.mohamed@med.asu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university | Recruiting | Cairo | Cairo Governorate | 11528 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36827944 | Background | 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. | |
| 34124099 | Result |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D046110 | Hypertension, Pregnancy-Induced |
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The trial is a pilot of randomized clinical, two parallel groups, 1:1 allocation, superiority study.
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both care providers are blinded: the ultrasound examiner will be blinded regarding the clinical evaluation of the airway.
the anesthesiologist will be blinded regarding the ultrasound airway assessment
| preoperative |
| Gomes 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. |
| 31725624 | Result | Zheng 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. |
| 12411285 | Result | Izci 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. |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |