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Assessing Effects of Lateral Tilt on Cardiac Output Using a Non-invasive Technique

Assessing Effects of Lateral Tilt on Cardiac Output Using a Non-invasive Technique

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04112719
Acronym
LATCOIN
Enrollment
50
Registered
2019-10-02
Start date
2019-11-01
Completion date
2020-04-01
Last updated
2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Output

Brief summary

In pregnant term patients, we intent to use a non invasive cardiac output monitor to detect the changes in cardiac output as the patient is being placed in different positions. The patient will be placed on her back, flat, and in left lateral tilt at two different angles. Measurements of cardiac output will be recorded.

Detailed description

Aortocaval compression compromising tissue perfusion has always been of a concern in term pregnant women undergoing caesarian delivery or regional anesthesia when placed in the supine position. It is believed that this phenomena happens when the gravid uterus compresses the inferior vena cava (IVC)resulting in decreased venous return and hence cardiac output (CO) leading to low placental perfusion and associated fetal heart rate changes. Hence, due to these concerns, left lateral tilt is currently a common practice in obstetrics and it is believed to relief aortocaval compression and to improve blood flow to the fetus. Supporting evidence for this intervention remains controversial, and shows conflicting results. Some studies suggest that lateral tilt does not affect neonatal outcomes (1) or changes in cardiac output in patients with no regional anesthesia (2). While others suggest it can actually increase the volume of the IVC, especially when the patient is tilted 30 degrees or more (3) and may lead to increases in CO (4). Non-invasive hemodynamic monitoring (NICOM, Cheetah Medical), an FDA approved device, is currently being used to detect changes in CO in the United States. Its use has been validated in different clinical settings (5,6). Our hypothesis is that CO is increased in pregnant women that were placed in the lateral tilt position. We intend to compare CO measurements using the non-invasive hemodynamic monitoring among term pregnant patients in supine vs lateral tilt position.

Interventions

OTHERsupine position

The patient will be placed in a supine position. Changes in cardiac output will be measured.

OTHER15 degrees lateral tilt

The patient will be placed in 15 degrees lateral tilt position. Changes in cardiac output will be measured.

OTHER30 degrees lateral tilt

The patient will be placed in 30 degrees lateral tilt position. Changes in cardiac output will be measured.

Sponsors

The University of Texas Medical Branch, Galveston
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Pregnant women between the ages of 18-50. * Elective repeat cesarean section or induction of labor.

Exclusion criteria

* Incarcerated patients * Patient unwilling or unable to provide consent * Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians).

Design outcomes

Primary

MeasureTime frameDescription
Cardiac output (liters/minute)20 minutesChanges in cardiac output while lying on bed at 45 degrees

Secondary

MeasureTime frameDescription
Blood pressure (mm Hg)80 minutesChanges in blood pressure while patient in placed in different positions
Fetal heart rate abnormalities (beats/minute)80 minutesChanges in fetal heart rate tracing while patient is placed in different positions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026