AI-guided automated fluid management for blood pressure control during laparoscopic colorectal surgery
Official title: The Assisted Fluid Management For High-Risk Patients During Colorectal Surgery: A Randomised Controlled Clinical Trial
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07366164 · Data updated 2026-11-12
This project will test whether an AI-guided automated fluid management system can help adults with ASA 3 undergoing laparoscopic colorectal surgery keep their blood pressure more stable and reduce episodes of low blood pressure during the operation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, RM) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07366164 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults older than 18 years with ASA physical status 3 who are scheduled for elective laparoscopic colorectal surgery, have BMI ≤ 35 kg/m2, are not pregnant, and can provide informed consent are ideal candidates.
✕Probably not a fit
Patients in urgent or emergency cases, those with BMI > 35 kg/m2, pregnant patients, children, or anyone who refuses consent are not eligible and would not be expected to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls adults over 18 with ASA physical status 3 who are scheduled for elective laparoscopic colorectal surgery. During the procedure, intraoperative fluid therapy will be guided by an automated AI-assisted system that provides real-time recommendations to the anesthesia team. The study will record hemodynamic measures such as mean arterial pressure, the incidence and duration of arterial hypotension, and fluid volumes administered. Collected outcomes will be used to see if automated guidance improves intraoperative hemodynamic stability and reduces hypotensive episodes.
Why it matters
Potential benefit: If successful, patients may experience more stable blood pressure during surgery with fewer hypotensive episodes and potentially fewer complications related to low organ perfusion.
How similar studies have gone: Previous studies of goal-directed and automated fluid-management systems in surgical patients have shown reductions in hypotension and some perioperative complications, though results have varied by clinical setting and device.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- patients \>18 years old and ASA 3 scheduled for laparoscopic colorectal surgery Exclusion Criteria: * Refusal of consent * Body Mass Index \> 35 kg/m2 * urgent cases * pregnancy
Where it's running
-
Fondazione Policlinico Universitario Policlinico Gemelli
Roma, Rm, Italy Recruiting
Study contacts
- Principal investigator: andrea russo — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: andrea russo, medical doctor
- Email: russoandreamd@gmail.com
- Phone: +393333926815
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.