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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University hospital Dubrava
  Zagreb, Croatia, Croatia Recruiting

Study contacts

• Study coordinator: Marko Pražetina, MD
• Email: mprazetina1991@gmail.com
• Phone: +385958150841

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.