NCT07514130

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

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

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Menoufia University · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Preeclampsia

Interventions

Type	Name	Description
DEVICE	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
DEVICE	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.
DRUG	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

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-07-20
• Completion: 2026-07-30
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: Egypt