Pregnancy Related Clinical Trial
Official title:
The Influence of Intravascular Fluid Administration on Aortic Velocity Time Integral in Obstetric Patients Undergoing Cesarean Section
NCT number | NCT04330742 |
Other study ID # | H45744 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 25, 2020 |
Est. completion date | December 31, 2025 |
Pregnancy is associated with a myriad of physiologic changes, including expansion of blood volume, decrease in oncotic pressure, and increased cardiac output. The obstetric population is associated with intrapartum hemorrhage. Accordingly, it is important to have an accurate method to assess fluid status in intrapartum patients. The use of standard volume assessment tools including arterial lines and central venous catheters is limited given the brevity of obstetric procedures and the morbidity of these techniques on the awake patients, and the costs. Non-invasive methods to assess volume status (carotid dopplers, direct measurement of blood loss, bio-impedance devices) are imperfect. Echocardiography is an attractive tool to measure fluid status in experienced operators such as anesthesiologists. IVC diameter and variation of aortic velocity time integral are two measures that can be obtained via echocardiography and been studied in spontaneously breathing patients. The purpose of this study is to determine whether these measurements can be used in the assessment of volume status in the laboring patient.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - healthy nulliparous or multiparous pregnant women with a term (>37 weeks gestation) - age 18-35 - singleton pregnancy - scheduled for Cesarean delivery with planned neuraxial spinal or combined spinal epidural anesthesia - American Society for Anesthesiologists physical status 2 Exclusion Criteria: - Patients without ability to provide informed consent - American Society for Anesthesiologists physical status 3 or 4 - Emergency cesarean section - BMI>40 - Known cardiac and pulmonary comorbidities including chronic hypertension, preeclampsia, gestational hypertension, diabetes, asthma, renal disease - Age > 35 |
Country | Name | City | State |
---|---|---|---|
United States | Ben Taub General Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | aortic velocity time integral | the percent change in aortic velocity time integral as measured by transthoracic echo | at baseline measure, right after spinal placement (250mL LR), at 500mL LR infusion, and at 1 L LR infusion (approximately 20mins) | |
Secondary | inferior vena cava collapsibility | the percent change in diameter of inferior vena cava as measured by transthoracic echo | at baseline measure, right after spinal placement (250mL LR), at 500mL LR infusion, and at 1 L LR infusion (approximately 20mins) | |
Secondary | change in systolic blood pressure | percent change in systolic blood pressure | every 2.5 mins for 20 mins (when 1L LR is administered) once the pt has a spinal placement | |
Secondary | change in heart rate | percent change in heart rate | every 2.5 mins for 20 mins (when 1L LR is administered) once the pt has a spinal placement |
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