Evaluation of Changes of Venous Return After Spinal and Epidural Analgesia and Anesthesia by Ultrasound Guided Vena Cava Diameter Measurement

Pregnancy Related Clinical Trial

Official title:

Evaluation of Changes of Venous Return After Spinal and Epidural Analgesia and Anesthesia by Ultrasound Guided Vena Cava Diameter Measurement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555799
• Other study ID #: 1194575
• Status: Completed
• Start date: May 18, 2018
• Est. completion date: June 15, 2019

Study information

• Verified date: July 2019
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 15, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Pregnant patients >37 weeks of gestation

2. Indication for neuraxial labor analgesia or regional anesthesia for cesarean section

3. Age older than 18 years

4. Pregnancy without diagnosed comorbidities

Exclusion criteria:

1. Unwillingness to participate in the study

2. Diagnosis of Hypertensive disorders of pregnancy

3. Diagnosis of cardiopulmonary disease

4. Allergy to US gel

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Pregnancy Related

Intervention

Diagnostic Test:
• Inferior vena cava ultrasound
Abdominal ultrasound to identify IVC between hepatic veins and right atrium. Measurement of dimensions throughout respiratory cycle (before and after labor epidural)

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IVC diameter	IVC diameter in centimeters during respiratory cycle	10 minutes
Secondary	Mean arterial pressure	Mean arterial pressure	30 minutes
Secondary	Nausea	Nausea	30 minutes