Agitated Saline, Albumin, or Propofol-albumin Mixture for Enhanced Contrast in TEE Examinations

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613052
• Other study ID #: 151360
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: September 2017

Study information

• Verified date: September 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• cardiac surgical patients requiring a transesophageal echocardiogram (TEE)

Exclusion Criteria:

• allergy to propofol

• inability to place a TEE probe

• inability to obtain a TEE bicaval image

• known right to left intracardiac shunt

• pt refusal to accept human blood products including albumin

• pt refusal to participate in study

• vulnerable patients (pregnant women, prisoners, cognitively impaired, or institutionalized)

Related Conditions & MeSH terms

• Psychomotor Agitation
• Transesophageal Echocardiography Contrast Agents

Intervention

Drug:
• normal saline
10 mL of normal saline agitated prior to IV administration
• human albumin
10 mL of 5% albumin agitated prior to IV administration
• human albumin and propofol
7 mL of 5% albumin mixed with 3 mL of propofol (10 mg/mL) agitated together prior to IV administration

Locations

Country	Name	City	State
United States	UC San Diego Sulpizio Cardiovascular Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (13)

Attaran RR, Ata I, Kudithipudi V, Foster L, Sorrell VL. Protocol for optimal detection and exclusion of a patent foramen ovale using transthoracic echocardiography with agitated saline microbubbles. Echocardiography. 2006 Aug;23(7):616-22. — View Citation

Baker MT, Naguib M. Propofol: the challenges of formulation. Anesthesiology. 2005 Oct;103(4):860-76. Review. — View Citation

Davison P, Clift PF, Steeds RP. The role of echocardiography in diagnosis, monitoring closure and post-procedural assessment of patent foramen ovale. Eur J Echocardiogr. 2010 Dec;11(10):i27-34. doi: 10.1093/ejechocard/jeq120. Review. — View Citation

de Jong N, Emmer M, van Wamel A, Versluis M. Ultrasonic characterization of ultrasound contrast agents. Med Biol Eng Comput. 2009 Aug;47(8):861-73. doi: 10.1007/s11517-009-0497-1. Epub 2009 May 26. — View Citation

Dewhirst E, et al. The Use of a Propofol-Saline Mixture for Enhanced Contrast in Bubble Studies During Echocardiographic Examinations. Society of Pediatric Anesthesia Meeting (Winter 2012).

Geny B, Mettauer B, Muan B, Bischoff P, Epailly E, Piquard F, Eisenmann B, Haberey P. Safety and efficacy of a new transpulmonary echo contrast agent in echocardiographic studies in patients. J Am Coll Cardiol. 1993 Oct;22(4):1193-8. — View Citation

Kitzman DW, Goldman ME, Gillam LD, Cohen JL, Aurigemma GP, Gottdiener JS. Efficacy and safety of the novel ultrasound contrast agent perflutren (definity) in patients with suboptimal baseline left ventricular echocardiographic images. Am J Cardiol. 2000 Sep 15;86(6):669-74. — View Citation

Meerbaum S. Introduction and general background. In: Myocardial Contrast Two-Dimensional Echocardiography, Meerbaum S, Meltzer R (Eds), Kluwer Academic Publishers, Boston 1989. p.2

Mulvagh SL, Rakowski H, Vannan MA, Abdelmoneim SS, Becher H, Bierig SM, Burns PN, Castello R, Coon PD, Hagen ME, Jollis JG, Kimball TR, Kitzman DW, Kronzon I, Labovitz AJ, Lang RM, Mathew J, Moir WS, Nagueh SF, Pearlman AS, Perez JE, Porter TR, Rosenbloom J, Strachan GM, Thanigaraj S, Wei K, Woo A, Yu EH, Zoghbi WA; American Society of Echocardiography. American Society of Echocardiography Consensus Statement on the Clinical Applications of Ultrasonic Contrast Agents in Echocardiography. J Am Soc Echocardiogr. 2008 Nov;21(11):1179-201; quiz 1281. doi: 10.1016/j.echo.2008.09.009. — View Citation

Porter TR, Abdelmoneim S, Belcik JT, McCulloch ML, Mulvagh SL, Olson JJ, Porcelli C, Tsutsui JM, Wei K. Guidelines for the cardiac sonographer in the performance of contrast echocardiography: a focused update from the American Society of Echocardiography. J Am Soc Echocardiogr. 2014 Aug;27(8):797-810. doi: 10.1016/j.echo.2014.05.011. Review. — View Citation

Shapiro JR, Reisner SA, Lichtenberg GS, Meltzer RS. Intravenous contrast echocardiography with use of sonicated albumin in humans: systolic disappearance of left ventricular contrast after transpulmonary transmission. J Am Coll Cardiol. 1990 Dec;16(7):1603-7. — View Citation

Stewart MJ. Contrast echocardiography. Heart. 2003 Mar;89(3):342-8. Review. — View Citation

Unger EC, Porter T, Culp W, Labell R, Matsunaga T, Zutshi R. Therapeutic applications of lipid-coated microbubbles. Adv Drug Deliv Rev. 2004 May 7;56(9):1291-314. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative enhancement in right atrial opacification during intraoperative TEE bubble studies	Number of participants with qualitatively enhanced right atrial opacification with albumin or albumin and propofol mixture compared to standard of care agitated normal saline, during TEE bubble studies using the bicaval view.	6 months