Ultrasound Airway Assessment of Critically Ill Preeclamptic; Comparison Between Two Technique
- Conditions
- Critical IllnessDifficult; Intubation, Postpartum, During PuerperiumPre-Eclampsia
- Registration Number
- NCT06651879
- Lead Sponsor
- Ain Shams University
- Brief 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. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 50
Critically ill preeclamptic patients for caesarean section under general anesthesia with the following criteria:
- Aged from 18 to 60 years.
- Singleton or multiple pregnancies,
- Mentally competent.
- American Society of Anesthesiologists (ASA) physical status I, II and III
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The predictivity of both us techniques in relation to clinical assessment of El-Ganzouri index (EGRI). 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 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.
- Secondary Outcome Measures
Name Time Method postoperative side effects within 24 hours postoperative Any postoperative adverse effects as patient discomfort from airway, mandibular pain or stridor
duration of the airway assessment preoperative 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
Trial Locations
- Locations (1)
Ain shams university
🇪🇬Cairo, Egypt