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Active, not recruiting Early Phase 1

Assessment of Volume Status in Preeclampsia Post- SpinalAnasthesia:Utilizing Ultrasound " Evaluation of Lung and Inferior Vena Cava"

NCT07514130 · tracked via the Priya Life Science Egypt tracker
Phase
Early Phase 1
Started
2024-08-01
Last updated
2026-04-07

Condition(s) studied

Preeclampsia

Investigational drug(s) / intervention(s)

Ultrasound lungultrasound for IVC diameterIntrathecal bupivacane

Ultrasound lung: Lung Ultrasound (LUS) Examination: Lung ultrasound will be performed using 2-5 MHz transducer, curved array (SonoAce R3; Samsung Medison, Seoul, South Korea). The 28-rib interspacestechniquewill used to calculate the Echo Comet Score (ECS), which divides the chest wall into 12 areas on the left (from the second to the fourth intercostal space) and 16 areas on the right (from the second to the fifth intercostal space) in each hemithorax, divided by the parasternal, midclavicular, anterior, and mid axillary lines. Multiple B-lines or "comet tails" can indicate an increased amount of extravascular lung water (EVLW).B-lines are vertical hyperechoic reverberation artifactsthat start from the pleural line and reach the bottom of the screen without fading and move synchronously with lung sliding. The ECS, which represents the amount of EVLW, is calculated by adding the overall number of B-lines observed on each of the 28 chest-wall locations and corresponding to the degree of pulmonary conges

ultrasound for IVC diameter: The IVC was scanned using a 2-4 MHz phased array transducer implanted longitudinally in the subcostal region. Duringnormalspontaneous breathing, the maximum and minimum IVC diameters were measured using the Mmodeabout 2 cm proximal (caudal) to the ostium of the right atrium and immediately proximal to the junction with the hepatic vein.

Intrathecal bupivacane: an anaesthesiologist with considerable experiencewilluse a 25-gauge spinal needle to provide spinal anesthesia at the L3-L4 or L4-L5 interspace, while the patient is in a sitting position; 12.5 mg ofhyperbaric bupivacaine (2.5 mL 0.5%) and 15 μg of fentanyl will be injected intrathecally

Study summary

Primary aim Assess the accuracy and reliability of ultrasound evaluation of lung and inferior vena cava in determining volume status post-spinal anesthesia in pre-eclampsia patients.

Measure the correlation between ultrasound findings and the traditional methods.

Determine if ultrasound evaluation can predict fluid responsiveness and guide fluid management in this population.

Secondary aim

The secondary outcomes are:

Investigate the association between volume status as determined by ultrasound and clinical outcomes such as maternal morbidity, neonatal outcomes, and length of hospital stay.

Explore the feasibility and practicality of incorporating ultrasound evaluation into routine clinical practice for volume assessment in pre-eclampsiapatients post-spinal anesthesia.

Consider patient satisfaction and acceptance of ultrasound evaluation compared to traditional methods.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
35 Years
Healthy volunteers
No
Inclusion criteria: * Age 20 to35 years * Gestational age 36 weeks * Body mass index (BMI) \<35kg/m2. * Mild preeclampsia Exclusion criteria : * Age \<19 or \>40 years, gestational age \<36 weeks, body mass index (BMI)≥40kg/m2. * Women presenting in emergency delivery. * Patient with other co morbidity sever cardiovascular or central nervous disease.

Primary outcome measure(s)

  • Lung ultrasound and IVC diameter — All baseline ultrasound examinations were performed by the principal investigator with the study patients lying supine with slight left lateral table-tilt. Subsequently, ultrasound examinations at 1hourwill be performed with the study patients lying supi
  • Primary aim Assess the accuracy and reliability of ultrasound evaluation of lung and inferior vena cava in determining volume status post-spinal anesthesia in pre-eclampsia patients. Measure the correlation between ultrasound findings and the traditional — 2 hour

Trial sites (1)

FacilityCityRegionStatus
Menofia University Shibīn al Kawm Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07514130 on ClinicalTrials.gov ↗ ← All trials in Egypt