Cardiac Output Changes With Uterine Displacement

Obstetric Anesthesia, Cardiac Monitoring Clinical Trial

— LUDCO  

Official title:

Assessement of Hemodynamic Changes Associated With Uterine Displacement Using Noninvasive Cardiac Output Monitoring and Transthoracic Echocardiography:

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02283931
• Other study ID #: 2014P002175
• Status: Suspended
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is currently little information regarding the hemodynamic differences in uterine displacement techniques. Previous studies examining the hemodynamic effects of uterine displacement maneuvers have focused on incidence of hypotension and use of ephedrine.

Noninvasive cardiac output monitoring (NICOM) and transthoracic echocardiography (TTE) are becoming popular techniques in anesthesiology because they can provide noninvasive, valid, and precise hemodynamic data.There has been no study specifically examining the hemodynamic differences between the uterine displacement techniques using NICOM or TTE. While all three uterine displacement techniques are recommended, whether one technique may maximize maternal cardiac output is currently unknown.

Description:

Aortocaval compression is a well-recognized physiologic concern in pregnancy. The gravid uterus can compress the inferior vena cava, impeding venous return and thereby reducing stroke volume and cardiac output.

The 2014 Society for Obstetric Anesthesia and Perinatology consensus statement on the management of cardiac arrest in pregnancy, and the 2010 American Heart Association guideline on maternal cardiac arrest recommend relieving aortocaval compression during chest compressions by performing uterine displacement There is currently little information regarding the hemodynamic differences amongst the recommended uterine displacement techniques. Previous studies examining the hemodynamic effects of uterine displacement maneuvers have focused on incidence of hypotension and use of ephedrine.

Noninvasive cardiac output monitoring (NICOM) and transthoracic echocardiography (TTE) are becoming popular techniques in anesthesiology because they can provide noninvasive, valid, and precise hemodynamic data.There has been no study specifically examining the hemodynamic differences between the uterine displacement techniques using NICOM or TTE. While all three uterine displacement techniques are recommended, whether one technique may maximize maternal cardiac output is currently unknown.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 25
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Healthy ASA physical status I-II

2. Term parturient

Exclusion Criteria:

1. Woman in labor

2. Presence of maternal medical conditions affecting the cardiovascular system (including preeclampsia, gestational hypertension)

3. Fetal anomaly or intrauterine growth restriction (< 25th percentile)

4. Maternal renal or endocrine disease

Related Conditions & MeSH terms

• Obstetric Anesthesia, Cardiac Monitoring

Intervention

Device:
• TTE / NICOM

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bamber JH, Dresner M. Aortocaval compression in pregnancy: the effect of changing the degree and direction of lateral tilt on maternal cardiac output. Anesth Analg. 2003 Jul;97(1):256-8, table of contents. — View Citation

Bieniarz J, Yoshida T, Romero-Salinas G, Curuchet E, Caldeyro-Barcia R, Crottogini JJ. Aortocaval compression by the uterus in late human pregnancy. IV. Circulatory homeostasis by preferential perfusion of the placenta. Am J Obstet Gynecol. 1969 Jan 1;103 — View Citation

Dennis A, Stenson A. The use of transthoracic echocardiography in postpartum hypotension. Anesth Analg. 2012 Nov;115(5):1033-7. doi: 10.1213/ANE.0b013e31826cde5f. Epub 2012 Oct 9. — View Citation

Lewis JF, Kuo LC, Nelson JG, Limacher MC, Quinones MA. Pulsed Doppler echocardiographic determination of stroke volume and cardiac output: clinical validation of two new methods using the apical window. Circulation. 1984 Sep;70(3):425-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Output		10 minutes