Cardiac and Pulmonary Complications. Central Venous Line Insertion. Gastrointestinal RecoveryNCT03058250

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

A study testing Transesophageal echocardiography in people with Cardiac and Pulmonary Complications. Central Venous Line Insertion. Gastrointestinal Recovery, run by University of Chicago.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac and Pulmonary Complications. Central Venous Line Insertion. Gastrointestinal Recovery
What is being tested?: Transesophageal echocardiography
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: No sites listed yet
Study dates: Dec 2012to May 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

About this study

Official title: 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.

Conditions: Cardiac and Pulmonary Complications. Central Venous Line Insertion. Gastrointestinal Recovery
Being tested: Transesophageal echocardiography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transesophageal echocardiographyOther

Study groups in NCT03058250
Study group	Role	What they receive
Control	No intervention	Standard of care, no intervention
Transesophageal echocardiography	Active comparator	Patients will have intraoperative transesophageal echocardiography along with standard of care for management. Receives: Other: Transesophageal echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

Decreased postoperative pulmonary and cardiac complications
Measured: approximately 5-7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012May 2016

First posted20 Feb 2017
Study startDec 2012
Primary completionMar 2014
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiac and Pulmonary Complications. Central Venous Line Insertion. Gastrointestinal RecoveryStudies of the same condition, open and under way.
More trials run by University of ChicagoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03058250
Sponsor's protocol ID: IRB12-1694
Status last verified: Feb 2023
First submitted: 13 Feb 2017
Last updated: 23 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Control Trial Comparing Routine Intraoperative Transesophageal Echocardiography During Radical Cystectomy to Standard of Care
ClinicalTrials.gov ID: NCT03058250
Acronym / sponsor ID: IRB12-1694
Conditions: Cardiac and Pulmonary Complications. Central Venous Line Insertion. Gastrointestinal Recovery
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Study start: Dec 2012 (actual)
Primary completion: Mar 2014 (actual)
Study completion: May 2016 (actual)
First posted: 20 Feb 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–Standard of care, no intervention
Transesophageal echocardiography	Active comparator	Other: Transesophageal echocardiographyPatients will have intraoperative transesophageal echocardiography along with standard of care for management.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transesophageal echocardiography	Other	Transesophageal echocardiography

Primary outcome

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

1 secondary outcome

Decreased postoperative pulmonary and cardiac complications
Time frame: approximately 5-7 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Transesophageal echocardiography in people with Cardiac and Pulmonary Complications. Central Venous Line Insertion. Gastrointestinal Recovery, run by University of Chicago.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of intraoperative central venous line insertion (time frame: 1 day after study enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03058250.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.