Clinical trial NCT04112719: Assessing Effects of Lateral Tilt on Cardiac Output Using a Non-invasive Technique
Official title: Assessing Effects of Lateral Tilt on Cardiac Output Using a Non-invasive Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term Pregnant women presenting for delivery

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Cardiac output (liters/minute)
timeFrame: 20 minutes
measure: Cardiac output (liters/minute)
timeFrame: 20 minutes
measure: Cardiac output (liters/minute)
timeFrame: 20 minutes
measure: Cardiac output (liters/minute)
timeFrame: 20 minutes
Secondary outcomes:
measure: Blood pressure (mm Hg)
timeFrame: 80 minutes
measure: Fetal heart rate abnormalities (beats/minute)
timeFrame: 80 minutes
Other outcomes:
Locations:
city: Galveston
country: United States
facility: UTMB
state: Texas
Study officials:
affiliation: UTMB
name: Antonio Saad, MD
role: STUDY_DIRECTOR
References: