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Clinical Trial Summary

The investigators propose this study to test the hypotheses that inferior vena cava (IVC) diameter can predict hypotension after labor analgesia (epidural, combined spinal-epidural) and neuraxial anesthesia for cesarean section (epidural, combined spinal-epidural and spinal block) in full-term pregnant patients.


Clinical Trial Description

After approval by the Institutional Review Board and patient consent, term pregnant patients (>37 week gestation) admitted to the obstetric service of Augusta University Medical Center, who require administration of neuraxial analgesia for labor or regional anesthesia for cesarean section, will be included in the study. The consent will be obtained by the attending, resident or medical student in which the investigators will explain to the patient the procedure, benefit, risk, cost and, confidentiality. The investigators plan to get the consent immediately after the patient arrived at the unit to avoid any interference with the delivery process. If the patient needs to go to an emergency cesarean section. This patient is not going to be included in the study. Demographic variables (age, BMI, Gravity, parity and gestation weeks) and hemodynamic variables (MAP and HR) will be recorded. All patients will be lying in supine position, breathing spontaneously. The ultrasound examination will be performed before commencement of the neuraxial procedure and will be repeated two minutes after administration of the neuraxial anesthetic. Ultrasound measurements will be made with a Sonosite Edge (Sonosite Inc. USA) machine and a C60X curved linear phased array transducer (Sonosite Inc.) set to abdominal mode. All measurements will be made by two attending anesthesiologists (ERP and AR) who have experience in transthoracic echocardiography, and a resident who receives the basic instruction to measure IVC diameter. The medical student will be present during the procedure and will ensure that the study echocardiographic views are taken.

The IVC will be visualized using a paramedian long-axis view via a subcostal approach according to guidelines of the American Society of Echocardiography. A two-dimensional image of the IVC will be obtained and pulsed wave Doppler will be used to differentiate from the aorta. Variations in IVC diameters will be assessed with M-mode applied 2 cm. distal to the right atrium. To ensure consistent measurements, each operator will take three images. The best quality images are chosen. Maximum and minimum IVC diameters during a single respiratory cycle will be measured. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03555799
Study type Observational
Source Augusta University
Contact
Status Completed
Phase
Start date May 18, 2018
Completion date June 15, 2019

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