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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac and Pulmonary Complications. Central Venous Line Insertion. Gastrointestinal Recovery
• Intervention / Treatment: Other: Transesophageal echocardiography

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care, no intervention
Active Comparator: Transesophageal echocardiography; Patients will have intraoperative transesophageal echocardiography along with standard of care for management.	Other: Transesophageal echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Decreased postoperative pulmonary and cardiac complications	approximately 5-7 days

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB12-1694

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No