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

NCT02613052 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-09-25

No results posted yet for this study

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.

Conditions

  • Transesophageal Echocardiography Contrast Agents

Interventions

DRUG

normal saline

10 mL of normal saline agitated prior to IV administration

DRUG

human albumin

10 mL of 5% albumin agitated prior to IV administration

DRUG

human albumin and propofol

7 mL of 5% albumin mixed with 3 mL of propofol (10 mg/mL) agitated together prior to IV administration

Sponsors & Collaborators

Principal Investigators

  • Swapnil Khoche, MD · University of California, San Diego

  • Ryan YS Suda, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-06-30
Completion
2017-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02613052 on ClinicalTrials.gov