Can Real-Time heart monitoring during trauma surgery save lives?
NCT ID NCT02742974
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers test whether using a minimally invasive heart monitor during surgery can reduce complications in severely injured trauma patients. The monitor, called FloTrac with the EV1000 platform, tracks blood flow and heart function continuously. Doctors use its readings to guide fluids and blood pressure drugs. The trial enrolls 48 adults with major injuries who need surgery within 72 hours of hospital admission.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- minimally invasive hemodynamic monitoring with the FloTrac sensor and EV1000 platform, plus protocol-directed fluid and vasopressor therapy
- What this could lead to
- If it works, this could give trauma teams a clearer way to guide fluids and blood pressure drugs during surgery, possibly lowering complications and deaths.
- What could go wrong
- The trial is small, with 48 participants, and uses a device that may not change outcomes. Monitoring carries small risks such as inaccurate readings or catheter-related problems.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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48 people
The number who actually took part.
- Started
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Oct 2015
- Finished
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Nov 2017
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. 18 years of age or older 2. Injury Severity Score \> 15 (indicator of anticipated trauma mortality) 3. Admission to Surgical-Trauma ICU (STICU) 4. Anticipated surgery within 72 hours of admission 5. American Society of Anesthesiology patient classification status (ASA) 2-5 6. Lactic acid \> 2.5 within 24 hours of surgical procedure or Base deficit ≥ - 5 mmol/L, or persistent requirement for vasopressor support within 24 hours of surgical procedure 7. Patient requires mechanical ventilation prior to consenting surgery 8. Vascular devices that include a minimum of an arterial line 9. Minimally invasive hemodynamic monitoring initiated prior to first surgical procedure unless patient is taken emergently, e.g. OR from trauma bay 10. Patients requiring emergent initial operative procedures will be eligible for consenting if above criteria are met prior to their second surgical procedure 11. Anticipated operative procedure precipitating evaluation and/or consenting for study must be \> 30 minutes in duration * Procedures \< 30 minutes would not result in significant metabolic stress necessitating a continuation of MIHM Exclusion Criteria: 1. Pregnancy 2. Exclusions due to limitations with respect to accuracy of MIHM: * Patients not intubated prior to surgical procedure * Patients requiring an open thoracotomy * Patients with known history of surgical intervention for peripheral vascular disease * Patients with pre-existing atrial arrhythmias * Patients who are on cardiopulmonary bypass 3. Isolated acute cerebral injury and/or traumatic cerebral injury * Hemodynamic management in this patient population does not always follow typical/standard endpoints due to nuances of managing intracranial pressures 4. Cardiac arrest prior to enrollment 5. Patients with pre-existing, dialysis dependent, renal failure upon admission * Hemodynamic management in this patient population does not always follow typical/standard endpoints due to nuances of managing renal failure 6. Patients with pre-existing cirrhosis * Hepatic failure results in abnormal clearance of lactic acid 7. Patients with no survival injuries, e.g. gunshot wound to the head
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Charleston Area Medical Center, General Hospital
Charleston, West Virginia, 25301, United States
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