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临床试验/CTRI/2025/09/094615
CTRI/2025/09/094615尚未招募不适用

COMPARISON OF ULTRASOUND BASED AIRWAY ASSESSMENT PARAMETERS IN PRE-ECLMAPTIC AND NORMOTENSIVE PARTURIENTS

Vardhaman Mahavir Medical College and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年9月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
108
试验地点
1
主要终点
To compare ultrasound-based airway assessment parameter- Anterior soft tissue thickness at level of epiglottis (ANS-E) in pre-eclamptic and normotensive parturients.

研究概览

简要总结

Difficult or unsuccessful tracheal intubation remains one of the most critical challenges faced by anaesthesiologists, particularly in emergency situations, obstetric cases, or when performed by less experienced practitioners. In obstetric patients, poor management of a difficult airway can lead to neonatal and maternal morbidity and mortality. Pregnancy is associated with various changes in anatomical and physiological changes that can complicate airway management. These include increased body weight, breast enlargement, and fluid retention, all of which contribute to soft tissue swelling and mucosal edema. These changes reduce airway calibre and make intubation more difficult. In hypertensive disorders of pregnancy, such as pre-eclampsia, the upper airway may become even more narrow compared to normotensive pregnant individuals. A variety of clinical tests and scoring systems are used to anticipate airway difficulty, but none—either alone or in combination—provide complete accuracy due to limitations in sensitivity and specificity. Ultrasonography has gained traction as a non-invasive, real-time tool for airway imaging. Ultrasound offers advantages such as real-time visualization, lack of radiation, and the ability to assess hidden airway structures, including the relationship between the tongue and oral cavity—making it a potentially reliable method for difficult airway prediction.Although ultrasound-based airway assessments have been studied in general adult populations, data specific to pregnant women remains limited. Parameters such as tongue thickness, oral cavity height, and soft tissue dimensions at the epiglottis, vocal cords, and hyoid levels, including the pre-epiglottic space, may offer valuable predictive information.This study aims to evaluate and compare ultrasound-based airway parameters in term normotensive parturients with those in parturients diagnosed with pre-eclampsia.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 18-45 years parturient with period of gestation more than 37 weeks ASA II and III with singleton pregnancy.

排除标准

  • Structural airway abnormalities, tumors and previous head and neck surgery.
  • Parturients with gestational diabetes, height less than 150 cm, body mass index (BMI) more than 30 kg/m2 (pre-pregnancy).

结局指标

主要结局

To compare ultrasound-based airway assessment parameter- Anterior soft tissue thickness at level of epiglottis (ANS-E) in pre-eclamptic and normotensive parturients.

时间窗: Ultrasound is used to asses airway parameter- Anterior soft tissue thickness at level of epiglottis (ANS-E) in pre-eclamptic and normotensive parturients.

次要结局

  • To Compare Ultrasound-Based Airway Assessment Parameters (Hyo-Mental Distance in Neutral Head Position, Tongue Thickness, Pre-E/E-VC, Subglottic Diameter.(To compare the ultrasound based airway assessment parameters in pre-eclamptic and normotensive parturients.)
  • To Compare Clinical Airway Assessment (Inter Incisor Distance, Modified Mallampati Class, Hyo-Mental Distance, Neck Circumference, Neck Movement and Upper Lip Bite Test) Parameters in Pre-Eclamptic and Normotensive Parturients.(To compare the clinical airway assessment in pre-eclamptic and normotensive parturients.)
  • To correlate these ultrasound based airway findings with clinical predictors of difficult airway (MMP greater than 3).(To draw correlation between ultrasound based airway assessment with clinical predictors of difficult airway.)

研究者

发起方
Vardhaman Mahavir Medical College and Safdarjung Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr A Arbika

VMMC and Safdarjung Hospital

研究点 (1)

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