Agitated Saline, Albumin, or Propofol-albumin Mixture for Enhanced Contrast in TEE Examinations
Completed · Not applicable
Conditions studied: Transesophageal Echocardiography Contrast Agents
In brief
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.
Key facts
- Study ID
- NCT02613052
- Run by
- University of California, San Diego
- People needed
- 17
- Starts
- 2016-01-01
- Expected to finish
- 2017-09-01
- Last updated by the study team
- 2019-09-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- cardiac surgical patients requiring a transesophageal echocardiogram (TEE)
You may not qualify if…
- 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)
Where it is running
- UC San Diego Sulpizio Cardiovascular Center — La Jolla, California, United States
Full record on ClinicalTrials.gov
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