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

Cardiac Output Clinical Trial

— LATCOIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112719
• Other study ID #: 19-0086
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: September 2019
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiac Output

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	UTMB	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output (liters/minute)	Changes in cardiac output while lying on bed at 45 degrees	20 minutes
Primary	Cardiac output (liters/minute)	Changes in cardiac output while patient in placed in supine position	20 minutes
Primary	Cardiac output (liters/minute)	Changes in cardiac output while patient in placed in lateral tilt at 15 degrees	20 minutes
Primary	Cardiac output (liters/minute)	Changes in cardiac output while patient in placed in lateral tilt at 30 degrees	20 minutes
Secondary	Blood pressure (mm Hg)	Changes in blood pressure while patient in placed in different positions	80 minutes
Secondary	Fetal heart rate abnormalities (beats/minute)	Changes in fetal heart rate tracing while patient is placed in different positions	80 minutes