Transesophageal Echocardiography Contrast Agents Clinical Trial
Official title:
The Use of Agitated Saline, Albumin, or a Propofol-albumin Mixture for Enhanced Contrast in Bubble Studies During Transesophageal Echocardiographic Examinations
This is a prospective, randomized, controlled study to determine if albumin and propofol or albumin only will provide superior qualitative contrast enhancement during TEE bubble studies compared to agitated saline. Each patient will receive three randomized bubble studies (agitated saline, albumin, and albumin and propofol) using 10 ml of agitated contrast agent. The albumin and propofol mixture will consist of 7 mL of 5% albumin plus 3 mL of propofol (10 mg/mL). Each patient will undergo qualitative review of all 3 bubble studies by 10 different anesthesiologists and/or cardiologists credentialed to read echocardiographic studies at the time of the surgical procedure, and also with retrospective review of the echo video (~200 studies). A bicaval view will be obtained to record a 20 beat loop for each bubble study. Hemodynamic variables prior to injection of contrast agent; and 30 seconds, 1 minute and 2 minutes after injection will be monitored and recorded.
This is a prospective, randomized, controlled study to determine if albumin and propofol or
albumin only will provide superior qualitative contrast enhancement during TEE bubble studies
compared to the current standard of care contrast agent, agitated saline. The study will take
place in the Operating Rooms (OR) at the UCSD Sulpizio Cardiovascular Center. The TEE studies
will be reviewed by UCSD Anesthesiology or Cardiology faculty who are credentialed to read
and interpret echocardiographic studies.
The study population will consist of 20 English-speaking patients and all will receive two
doses of contrast, namely agitated albumin or propofol and albumin mixture, undergoing
cardiac surgery who require TEE. Each patient will undergo qualitative review by 10
anesthesiologists and/or cardiologists credentialed to read echocardiographic studies at the
time of the surgical procedure, and also with retrospective review of the echo video. The
multiple reviewers per patient will increase the power of the study (~200 studies). Each
patient will receive three bubble studies using 10 ml of agitated contrast agent as named
above. The order in which each contrast agent is utilized, as well as the experimental
contrast agent, is randomized and the interpreting physician is blinded to this information.
Agitated saline (AS) alone will be used as a (third dose) control for each patient, which is
the current standard contrast agent for TEE bubble studies. The other bubble studies will use
an experimental agitated contrast agent, either a mixture of 7 mL albumin and 3 mL propofol
(10 mg/ml) or 10 mL albumin (human). Saline and albumin 5% are intravenous fluids FDA
approved for the use in restoration and maintenance of circulating of blood volume. Propofol
is FDA approved for the use in induction or maintenance of general anesthesia.
The anesthesia care team, as per the standard care during UCSD cardiac surgical procedures,
will place a TEE probe after induction of general anesthesia and endotracheal intubation.
During the initial TEE exam, a bicaval view will be obtained. Both the order and type of
experimental agitated contrast agent will be randomized and blinded to the sonographer and
reviewer. A 20 beat loop will be recorded for each bubble study. Hemodynamic variables prior
to injection of contrast agent; and 30 seconds, 1 minute and 2 minutes after injection are
monitored and recorded. All recorded data will be anonymized prior to review. TEE is standard
of care and routinely used in the care of cardiac surgery patients and is not performed
solely for this study.
All anesthetic, surgical and medical interventions will be chosen and carried out by the
surgical and anesthesia teams, including those involving invasive monitor placement, fluid
administration, ventilator management and patient positioning.
Appropriate statistical analysis will be utilized to evaluate the difference in contrast
enhancement in the saline only, albumin, and albumin and propofol groups.
The results of the study will be published in the peer-reviewed medical literature.
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