Cardiac Output Changes With Uterine Displacement

NCT ID: NCT02283931

Last Updated: 2022-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2023-12-30

Brief Summary

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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

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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.

Conditions

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Obstetric Anesthesia, Cardiac Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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One handed uterine displacement

Uterine displacement using one hand

Group Type ACTIVE_COMPARATOR

TTE / NICOM

Intervention Type DEVICE

two handed uterine displacement

Uterine displacement using two hands

Group Type ACTIVE_COMPARATOR

TTE / NICOM

Intervention Type DEVICE

30 degrees uterine displacement

Uterine displacement using a 30 degrees wedge

Group Type ACTIVE_COMPARATOR

TTE / NICOM

Intervention Type DEVICE

Interventions

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TTE / NICOM

Intervention Type DEVICE

Other Intervention Names

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Transthoracic Echocardiography / Noninvasive Cardiac Output Monitor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lawrence Ching Tsen

Associate Professor, Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 5761773 (View on PubMed)

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.

Reference Type RESULT
PMID: 12818977 (View on PubMed)

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.

Reference Type RESULT
PMID: 6744546 (View on PubMed)

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.

Reference Type RESULT
PMID: 23051881 (View on PubMed)

Other Identifiers

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2014P002175

Identifier Type: -

Identifier Source: org_study_id

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