AI-guided automated fluid management for blood pressure control during laparoscopic colorectal surgery
The Assisted Fluid Management For High-Risk Patients During Colorectal Surgery: A Randomised Controlled Clinical Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT07366164 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma, RM
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.