Assessing Effects of Lateral Tilt on Cardiac Output Using a Non-invasive Technique
NCT ID: NCT04112719
Last Updated: 2020-10-26
Study Results
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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COMPLETED
50 participants
OBSERVATIONAL
2019-11-01
2020-04-01
Brief Summary
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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
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Control arm/pregnant patients at term
Control arm where the term pregnant patient will be lying on the bed at 45 degrees.
No interventions assigned to this group
Experimental/Supine
Term pregnant patient will be positioned in supine. Changes in hemodynamics will be measured.
supine position
The patient will be placed in a supine position. Changes in cardiac output will be measured.
Experimental/15 degrees lateral tilt
Term pregnant patient will be positioned at 15 degrees in lateral tilt. Changes in hemodynamics will be measured.
15 degrees lateral tilt
The patient will be placed in 15 degrees lateral tilt position. Changes in cardiac output will be measured.
Experimental/30 degrees lateral tilt
Term pregnant patient will be positioned at 30 degrees in lateral tilt. Changes in hemodynamics will be measured.
30 degrees lateral tilt
The patient will be placed in 30 degrees lateral tilt position. Changes in cardiac output will be measured.
Interventions
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supine position
The patient will be placed in a supine position. Changes in cardiac output will be measured.
15 degrees lateral tilt
The patient will be placed in 15 degrees lateral tilt position. Changes in cardiac output will be measured.
30 degrees lateral tilt
The patient will be placed in 30 degrees lateral tilt position. Changes in cardiac output will be measured.
Eligibility Criteria
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Inclusion Criteria
* Elective repeat cesarean section or induction of labor.
Exclusion Criteria
* Patient unwilling or unable to provide consent
* Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians).
18 Years
50 Years
FEMALE
Yes
Sponsors
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The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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Antonio Saad, MD
Role: STUDY_DIRECTOR
UTMB
Locations
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UTMB
Galveston, Texas, United States
Countries
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Other Identifiers
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19-0086
Identifier Type: -
Identifier Source: org_study_id