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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Output
• Intervention / Treatment: Other: supine position; Other: 15 degrees lateral tilt; Other: 30 degrees lateral tilt

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • UTMB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Term Pregnant women presenting for delivery

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control arm/pregnant patients at term; Control arm where the term pregnant patient will be lying on the bed at 45 degrees.
Experimental/Supine; Term pregnant patient will be positioned in supine. Changes in hemodynamics will be measured.	Other: 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.	Other: 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.	Other: 30 degrees lateral tilt; The patient will be placed in 30 degrees lateral tilt position. Changes in cardiac output will be measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output (liters/minute)	Changes in cardiac output while lying on bed at 45 degrees	20 minutes
Cardiac output (liters/minute)	Changes in cardiac output while patient in placed in supine position	20 minutes
Cardiac output (liters/minute)	Changes in cardiac output while patient in placed in lateral tilt at 15 degrees	20 minutes
Cardiac output (liters/minute)	Changes in cardiac output while patient in placed in lateral tilt at 30 degrees	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure (mm Hg)	Changes in blood pressure while patient in placed in different positions	80 minutes
Fetal heart rate abnormalities (beats/minute)	Changes in fetal heart rate tracing while patient is placed in different positions	80 minutes

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Study Director: Antonio Saad, MD, UTMB

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 19-0086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No