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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03555799
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : June 14, 2018
Information provided by (Responsible Party):
Efrain Riveros Perez, Augusta University

Brief Summary:
We 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.

Condition or disease Intervention/treatment
Pregnancy Related Hypotension, Orthostatic Diagnostic Test: Inferior vena cava ultrasound

Detailed 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 we will explain to the patient the procedure, benefit, risk, cost and, confidentiality. We 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 Type : Observational
Estimated Enrollment : 89 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Evaluation of Changes of Venous Return After Spinal and Epidural Analgesia and Anesthesia by Ultrasound Guided Vena Cava Diameter Measurement
Actual Study Start Date : May 18, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Labor analgesia patients
Patients with clinical indication of labor epidural will have IVC diameter measurement with ultrasound before and after the epidural placement
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)

Primary Outcome Measures :
  1. IVC diameter [ Time Frame: 10 minutes ]
    IVC diameter in centimeters during respiratory cycle

Secondary Outcome Measures :
  1. Mean arterial pressure [ Time Frame: 30 minutes ]
    Mean arterial pressure

  2. Nausea [ Time Frame: 30 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Parturients in labor
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Term pregnant patients in labor who have labor epidural placement.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03555799

Contact: Efrain Riveros Perez, MD 7067217361
Contact: Alexander Rocuts Martinez, MD 7067218495

United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Steffen Meiler, MD    706-721-3671   
Sponsors and Collaborators
Augusta University

Responsible Party: Efrain Riveros Perez, Assistant Professor Department of Anesthesiology and Perioperative Medicine, Augusta University Identifier: NCT03555799     History of Changes
Other Study ID Numbers: 1194575
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypotension, Orthostatic
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases