Trial Comparing Routine Intraoperative Transesophageal Echocardiography During Radical Cystectomy to Standard of Care

The University of Chicago

Status: Completed

Conditions: Cardiac and Pulmonary Complications. Central Venous Line Insertion. Gastrointestinal Recovery

Treatments: Other: Transesophageal echocardiography

Study type: Interventional

Funder types: Other

Identifiers

NCT03058250

IRB12-1694

Details and patient eligibility

About

This is a prospective randomized controlled trial looking at the utility of intraoperative transesophageal echocardiography (TEE) on clinical outcomes after radical cystectomy. Patients in the control group will have standard of care, patients in the TEE group will have standard of care and TEE monitoring throughout. Intraoperative and postoperative variables, such time to extubation, postoperative cardiac and pulmonary complications, intraoperative fluid and vasopressor use will be assessed.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients have elective radical cystectomy at The University of Chicago Hospital.

Exclusion criteria

• Patient refusal, emergent surgery, preoperative mechanical ventilation, preoperative hemodynamic instability (intravenous vasopressor support), and/or esophageal/gastric pathology contraindicating insertion of the transesophageal echocardiography probe.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Control

No Intervention group

Description:

Standard of care, no intervention

Transesophageal echocardiography

Active Comparator group

Description:

Patients will have intraoperative transesophageal echocardiography along with standard of care for management.

Treatment:

Other: Transesophageal echocardiography