Cardiac OutputLATCOINNCT04112719
Assessing Effects of Lateral Tilt on Cardiac Output Using a Non-invasive Technique
An observational study of Cardiac Output, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiac Output
- What is being tested?
- supine position, 15 degrees lateral tilt and 30 degrees lateral tilt
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 1 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Term Pregnant women presenting for delivery
Who may be able to join
- Pregnant women between the ages of 18-50.
- Elective repeat cesarean section or induction of labor.
Who cannot join
- Incarcerated patients
- Patient unwilling or unable to provide consent
- Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cardiac Output
- Being tested
- supine position, 15 degrees lateral tilt, 30 degrees lateral tilt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supine positionOther
The patient will be placed in a supine position. Changes in cardiac output will be measured.
15 degrees lateral tiltOther
The patient will be placed in 15 degrees lateral tilt position. Changes in cardiac output will be measured.
30 degrees lateral tiltOther
The patient will be placed in 30 degrees lateral tilt position. Changes in cardiac output will be measured.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: 30 degrees lateral tilt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output (liters/minute)
Changes in cardiac output while lying on bed at 45 degrees
Measured: 20 minutes
Cardiac output (liters/minute)
Changes in cardiac output while patient in placed in supine position
Measured: 20 minutes
Cardiac output (liters/minute)
Changes in cardiac output while patient in placed in lateral tilt at 15 degrees
Measured: 20 minutes
Cardiac output (liters/minute)
Changes in cardiac output while patient in placed in lateral tilt at 30 degrees
Measured: 20 minutes
Secondary outcomes (2)
Blood pressure (mm Hg)
Changes in blood pressure while patient in placed in different positions
Measured: 80 minutes
Fetal heart rate abnormalities (beats/minute)
Changes in fetal heart rate tracing while patient is placed in different positions
Measured: 80 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Nov 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac OutputStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Saad, MD, Study director, UTMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112719
- Sponsor's protocol ID
- 19-0086
- Acronym
- LATCOIN
- Status last verified
- Sep 2019
- First submitted
- 24 Sep 2019
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Effects of Lateral Tilt on Cardiac Output Using a Non-invasive Technique
- ClinicalTrials.gov ID
- NCT04112719
- Acronym / sponsor ID
- LATCOIN / 19-0086
- Conditions
- Cardiac Output
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control arm/pregnant patients at term | – | –Control arm where the term pregnant patient will be lying on the bed at 45 degrees. |
| Experimental/Supine | – | Other: supine positionTerm pregnant patient will be positioned in supine. Changes in hemodynamics will be measured. |
| Experimental/15 degrees lateral tilt | – | Other: 15 degrees lateral tiltTerm pregnant patient will be positioned at 15 degrees in lateral tilt. Changes in hemodynamics will be measured. |
| Experimental/30 degrees lateral tilt | – | Other: 30 degrees lateral tiltTerm pregnant patient will be positioned at 30 degrees in lateral tilt. Changes in hemodynamics will be measured. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Term Pregnant women presenting for delivery
Key inclusion criteria (2 listed)
- Pregnant women between the ages of 18-50.
- Elective repeat cesarean section or induction of labor.
Key exclusion criteria (3 listed)
- Incarcerated patients
- Patient unwilling or unable to provide consent
- Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supine positionThe patient will be placed in a supine position. Changes in cardiac output will be measured. | Other | Experimental/Supine |
| 15 degrees lateral tiltThe patient will be placed in 15 degrees lateral tilt position. Changes in cardiac output will be measured. | Other | Experimental/15 degrees lateral tilt |
| 30 degrees lateral tiltThe patient will be placed in 30 degrees lateral tilt position. Changes in cardiac output will be measured. | Other | Experimental/30 degrees lateral tilt |
Primary outcome
Cardiac output (liters/minute)
Time frame: 20 minutes
Changes in cardiac output while lying on bed at 45 degrees
Cardiac output (liters/minute)
Time frame: 20 minutes
Changes in cardiac output while patient in placed in supine position
Cardiac output (liters/minute)
Time frame: 20 minutes
Changes in cardiac output while patient in placed in lateral tilt at 15 degrees
Cardiac output (liters/minute)
Time frame: 20 minutes
Changes in cardiac output while patient in placed in lateral tilt at 30 degrees
2 secondary outcomes
Blood pressure (mm Hg)
Time frame: 80 minutes
Fetal heart rate abnormalities (beats/minute)
Time frame: 80 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Saad, MD study director
UTMB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Output, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (liters/minute) (time frame: 20 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.