跳至主要内容
临床试验/NCT06651879
NCT06651879招募中不适用

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

Ain Shams University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年7月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
The predictivity of both us techniques in relation to clinical assessment of El-Ganzouri index (EGRI).

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Care Provider)

盲法说明

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

入排标准

性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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

干预措施: techniques of ultrasound examination of the airway (Diagnostic Test)

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

干预措施: techniques of ultrasound examination of the airway (Diagnostic Test)

结局指标

主要结局

The predictivity of both us techniques in relation to clinical assessment of El-Ganzouri index (EGRI).

时间窗: 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

时间窗: 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.

次要结局

  • postoperative side effects(within 24 hours postoperative)
  • duration of the airway assessment(preoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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