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

RecruitingNAAges 50 Years - anyAllUniversity Hospital Dubrava
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In plain words

What the trial is, and whether it could suit you

This study will include patients aged 50 and older scheduled for elective abdominal oncologic surgery, classified as ASA II and III due to increased anaesthetic and surgical risk. Gender will not be a stratification factor. Exclusion criteria include patient refusal, memory impairment, psychosis, known or suspected EEG abnormalities, chronic psychoactive medication use, urgent procedures, BMI below 18 kg/mยฒ or above 35 kg/mยฒ, persistent arrhythmias, NYHA class III-IV heart failure, valvular disease, liver diseases, and anticipated surgery duration over six hours. Eligible patients must sign an informed consent form one day prior to surgery. Demographic data collected will include age, sex, operation type, comorbidities, ASA status, height, weight, and BMI. Randomisation will occur before the study begins with a sample size of 100 subjects based on a pilot study of 5 patients per group.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Multimodal monitoring
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Where

1 site
University hospital Dubrava
Zagreb, Croatia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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