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New heart monitor may cut hospital stays after bypass surgery

NCT ID NCT01535716

Disease control Sponsor: University Hospital, Caen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a special monitor placed in the breathing tube during heart bypass surgery could help doctors manage fluids and blood flow better. 100 adults having elective coronary bypass surgery were split into two groups: one got standard care, the other used the ECOM monitor. The goal was to see if the monitor could reduce hospital stays and serious heart problems after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Endotracheal cardiac output monitoring (ECOM) system
What this could lead to
If it works, this could lead to shorter hospital stays and fewer heart complications after coronary bypass surgery.
What could go wrong
This is a small, completed Phase 4 trial with only 100 patients, so results may not apply to everyone. The device is still not widely used, and benefits over standard care are uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

100 people

The number who actually took part.

Start date

Feb 2012

Finished

Feb 2013

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Any man or woman * Over 18 year-old * After obtaining written informed consent * Scheduled for elective coronary surgery with CPB Exclusion Criteria: * Emergency surgery (\< 24h) * Combined cardiac surgery * Patients \< 18 years-old and/or unable to give informed consent * Patients who refuse to give informed consent * Pregnancy * PVC allergy

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary surgery with cardiopulmonary bypass

Contacts and locations

Locations

  • University Hospital of Caen

    Caen, Calvados, 14000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.