Clinical Trials Directory

Trials / Completed

CompletedNCT04112719

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

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
The University of Texas Medical Branch, Galveston · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERsupine positionThe patient will be placed in a supine position. Changes in cardiac output will be measured.
OTHER15 degrees lateral tiltThe patient will be placed in 15 degrees lateral tilt position. Changes in cardiac output will be measured.
OTHER30 degrees lateral tiltThe patient will be placed in 30 degrees lateral tilt position. Changes in cardiac output will be measured.

Timeline

Start date
2019-11-01
Primary completion
2020-04-01
Completion
2020-04-01
First posted
2019-10-02
Last updated
2020-10-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04112719. Inclusion in this directory is not an endorsement.