Completed

NCT Number: NCT03058250

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.

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transesophageal echocardiography

Other

Primary outcomes

Incidence of intraoperative central venous line insertion

Time frame: 1 day after study enrollment
postoperative return of bowel function via flatus or passage of stool

Time frame: 5 days after study enrollment

Secondary outcomes

Decreased postoperative pulmonary and cardiac complications

Time frame: approximately 5-7 days

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2016
First posted: Feb 20, 2017
Registry last updated: Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.