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

Not Applicable

Completed

• Conditions: Cardiac and Pulmonary Complications. Central Venous Line Insertion. Gastrointestinal Recovery
• Interventions: Other: Transesophageal echocardiography

• Registration Number: NCT03058250
• Lead Sponsor: University of Chicago

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2014-03
• Study Completion: 2016-05
• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transesophageal echocardiography	Transesophageal echocardiography	Patients will have intraoperative transesophageal echocardiography along with standard of care for management.

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative central venous line insertion	1 day after study enrollment
postoperative return of bowel function via flatus or passage of stool	5 days after study enrollment

Secondary Outcome Measures

Name	Time	Method
Decreased postoperative pulmonary and cardiac complications	approximately 5-7 days