Using extra intraoperative monitoring during major abdominal cancer operations to reduce time on a ventilator

Intraoperative Multimodal Monitoring as a Means in Reducing the Duration of Mechanical Ventilation in High-Risk Patients Undergoing Major Abdominal Procedures - A Pilot Study

This study will test whether adding multimodal monitors during elective major abdominal cancer surgery can help patients aged 50 and older spend less time on mechanical ventilation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: University Hospital Dubrava (Academic / other)
• Locations: 1 site (Zagreb, Croatia)
• Trial ID: NCT07339449 on ClinicalTrials.gov

What this trial studies

This is a randomized, pilot interventional study enrolling 100 patients aged 50 or older undergoing elective major abdominal oncologic surgery with ASA II–III risk. Participants are randomized to receive standard care or additional intraoperative multimodal monitoring (for example cardiac output measures and cerebral oximetry) with protocolized responses to the monitored data. Key exclusions include urgent procedures, BMI <18 or >35 kg/m², persistent arrhythmias, severe heart failure, significant valvular or liver disease, known EEG abnormalities, chronic psychoactive medication use, and anticipated surgery >6 hours. Demographics and perioperative data will be collected and ventilation duration will be compared between groups.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50 or older scheduled for elective major abdominal oncologic surgery with ASA II–III status who meet BMI and cardiac/liver function criteria and can provide informed consent.

Not a fit: Patients undergoing urgent/emergent surgery, with extreme BMI (<18 or >35), persistent arrhythmias, severe heart failure, significant valvular or liver disease, known EEG disorders, or chronic psychoactive medication use are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could shorten the time patients need mechanical ventilation after major abdominal surgery and reduce ventilation-related complications and ICU time.

How similar studies have performed: Components such as goal-directed hemodynamic optimization and cerebral oximetry have shown benefits for postoperative complications and sometimes shorter ICU stays, but using a combined multimodal intraoperative monitoring package specifically to reduce ventilation duration is relatively novel and not yet tested in large trials.

Eligibility criteria

Inclusion Criteria:

* aged 50 years or older
* scheduled for elective major abdominal surgery, specifically those classified as ASA II and ASA III

Exclusion Criteria:

* patient refusal;
* memory impairment (psychosis);
* known or suspected electroencephalo-graphic abnormalities (such as epilepsy or previous brain surgery);
* chronic use of psy-choactive medication;
* urgent or emergent procedures;
* body mass index (BMI) below 18 kg/m2 or above 35 kg/m2;
* persistent arrhythmias including atrial fibrillation and undulation;
* documented NYHA class III-IV heart failure or a preoperative left ventricular ejection fraction below 30%;
* valvular disease involving aortic and/or mitral stenosis or regurgita-tion;
* liver diseases such as decompensated cirrhosis and coagulopathies;
* anticipated operation duration exceeding six hours.

Where this trial is running

Zagreb, Croatia

• University hospital Dubrava — Zagreb, Croatia, Croatia (Recruiting)

Study contacts

• Study coordinator: Marko Pražetina, MD

Conditions Major Abdominal Surgeries; Mechanical Ventilation; Abdominal surgery; minimally invasive; cardiac output; cerebral oximetry; multimodal monitoring