Clinical trial NCT06651879: Ultrasound Airway Assessment of Critically Ill Preeclamptic; Comparison Between Two Technique
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Difficult; Intubation, Postpartum, During Puerperium
Pre-Eclampsia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial is a pilot of randomized clinical, two parallel groups, 1:1 allocation, superiority study.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria: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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The predictivity of both us techniques in relation to clinical assessment of El-Ganzouri index (EGRI).
timeFrame: 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
measure: The predictive superiority between 2 view and 5 views ultrasound techniques regarding difficult ventilation, laryngoscopy and intubation
timeFrame: 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:
measure: postoperative side effects
timeFrame: within 24 hours postoperative
measure: duration of the airway assessment
timeFrame: preoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.