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

NCT07514130 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-04-07

No results posted yet for this 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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Menoufia University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-07-20
Completion
2026-07-30

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07514130 on ClinicalTrials.gov