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

Cardiac and Pulmonary Complications. Central Venous Line Insertion. Gastrointestinal Recovery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058250
• Other study ID #: IRB12-1694
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: May 2016

Study information

• Verified date: February 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2016
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac and Pulmonary Complications. Central Venous Line Insertion. Gastrointestinal Recovery

Intervention

Other:
• Transesophageal echocardiography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of intraoperative central venous line insertion		1 day after study enrollment
Primary	postoperative return of bowel function via flatus or passage of stool		5 days after study enrollment
Secondary	Decreased postoperative pulmonary and cardiac complications		approximately 5-7 days