Clinical trial NCT02283931: Cardiac Output Changes With Uterine Displacement
Official title: Assessement of Hemodynamic Changes Associated With Uterine Displacement Using Noninvasive Cardiac Output Monitoring and Transthoracic Echocardiography:
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Obstetric Anesthesia, Cardiac Monitoring
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac Output
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
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(1):19-31. doi: 10.1016/s0002-9378(16)34335-6. No abstract available.
citation: 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. doi: 10.1213/01.ane.0000067400.79654.30.
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. doi: 10.1161/01.cir.70.3.425.
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. No abstract available.