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

NCT04112719 | Completed

• 1 other identifier: 19-0086
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Output

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Blood pressure (mm Hg)

  80 minutes

• Fetal heart rate abnormalities (beats/minute)

  80 minutes

Study Arms (4)

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

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

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

Interventions

supine position OTHER

The patient will be placed in a supine position. Changes in cardiac output will be measured.

Experimental/Supine

15 degrees lateral tilt OTHER

The patient will be placed in 15 degrees lateral tilt position. Changes in cardiac output will be measured.

Experimental/15 degrees lateral tilt

30 degrees lateral tilt OTHER

The patient will be placed in 30 degrees lateral tilt position. Changes in cardiac output will be measured.

Experimental/30 degrees lateral tilt

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Term Pregnant women presenting for delivery

You may qualify if:

• Pregnant women between the ages of 18-50.
• Elective repeat cesarean section or induction of labor.

You may not qualify if:

• Incarcerated patients
• Patient unwilling or unable to provide consent
• Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians).

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

UTMB

Galveston, Texas, 77555, United States

Location

MeSH Terms

Interventions

Supine Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Antonio Saad, MD

  UTMB

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: October 2, 2019
• Study Start: November 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: October 26, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)