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

NCT07339449 | Recruiting DMC FDA Device

• 1 other identifier: 2025/ 0603-8
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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/m² or above 35 kg/m², 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. Premedication and Monitoring: Patients will receive premedication per institutional protocol, which includes intramuscular midazolam. Intraoperative monitoring follows randomisation allocation. The control group will have standard measurements, including invasive pressure and ECG. Data collection will be handled by designated team members who will archive anaesthesia charts. After intubation, patients will be ventilated with 6-8 ml/kg of predicted body weight and a fresh gas flow of 1 L/min. Intervention Group Protocol: In the intervention group, monitoring will be established via radial artery cannulation under local anaesthesia, using LiDCOrapid®, Rainbow®, and Hb attachments. Baseline MAP and CO values will be recorded, with DO2 calculated automatically. Sensors will be positioned to monitor anaesthetic depth and rSO2 before pre-oxygenation. A noradrenaline infusion will maintain venous tone. Anaesthesia will use TCI with propofol and sufentanil, targeting specific values based on age groups. The primary goal is to maintain an rSO2 of at least 85% of baseline. If rSO2 falls below this threshold, a DO2 optimisation protocol will be initiated, adjusting conditions and administering fluids and medications as necessary. Control Group Protocol: In the control group, propofol and sufentanil will be administered as previously outlined with adjustments based on intraoperative responses and awareness. Rocuronium bromide will be used for neuromuscular blockade, with monitoring and administration of fluids managed by the attending anaesthesiologist. Data Recording: All data during procedures will be recorded digitally or manually, and post-procedure data will be downloaded for analysis. Patients will be transferred to the ICU for postoperative monitoring. Laboratory Analysis: Blood samples for routine analysis will be collected at three time points: prior to surgery, upon ICU admission, and 24 hours after. Parameters assessed include complete blood count, electrolyte levels, PT, aPTT, fibrinogen, blood gas parameters, lactate, troponin I, and NTproBNP. Outcome Measurements: Both groups will be monitored for duration of anaesthesia, drug administration, fluid volume, postoperative complications, mortality rates, and ICU length of stay (LOS). Continuous variables will be reported using descriptive statistics or interquartile ranges, while categorical variables will be shown as counts and percentages. Statistical analysis will be performed using Mann Whitney U test for continuous variables, repeated measures ANOVA for group comparisons, and chi-squared tests for categorical variables. ANCOVA will be employed to compare clinical outcomes with age as a covariate. The software package jamovi v2.5.3 will be utilized for statistical analysis with a significance level set at p \< 0.05.

Conditions

Major Abdominal Surgeries; Mechanical Ventilation

Keywords

Abdominal surgery; minimally invasive; cardiac output; cerebral oximetry; multimodal monitoring

Outcome Measures

Primary Outcomes (1)

• Duration of mechanical ventilation

  Patients in the Interventional group should have shorter duration of mechanical ventilation after surgery

  From enrollment to the end of treatment at 30 days

Secondary Outcomes (9)

• troponin I levels

  From enrollment to the end of treatment at 30 days

• NTproBNP levels

  From enrollment to the end of treatment at 30 days

• Lactate levels

  From enrollment to the end of treatment at 30 days

• postoperative medical complications

  From enrollment to the end of treatment at 30 days

• post-operative surgical complications

  From enrollment to the end of treatment at 30 days

Study Arms (2)

Interventional

EXPERIMENTAL

Radial artery cannulation insertion before induction, LiDCOrapid®, Rainbow®, and haemoglobin attachment to the Root® monitor. Baseline measurements of MAP and CO, DO2 will be calculated from CO and haemoglobin values. SedLine® and O3® sensors will be placed to measure baseline anaesthetic depth and rSO2 before pre-oxygenation. Noradrenaline infusion will be initiated.Anaesthesia induction and maintenance will follow a TCI protocol with propofol and sufentanil, targeting a PSI between 30-50. The goal is rSO2 at or above 85% of baseline. If rSO2 drops below, a DO2 optimisation protocol will be activated, confirming anaesthetic depth and SpO2 levels. If SVV exceeds 12%, a 250 ml crystalloid bolus will be administered until SVV decreases. If SVRI is below 1600 dynes·s·m²/cm⁵, a norepinephrine bolus will be administered. CI will be monitored, and dobutamine will start if CI drops below 2.4 L/min/m². If rSO2 still remains low , head position, FIO2 and PEEP changes will be made.

Device: Multimodal monitoring

Control

NO INTERVENTION

Sufentanil and propofol TCI dosing will be administered using Gepts and Schnider effect-site models, respectively. The anaesthesiologist will monitor the effect-site concentration of propofol during induction, titrating until the loss of eyelash reflex and response to verbal stimuli occur. The dose will then be increased by 20% and maintained until surgery completion. Following intubation, 0.03 mg/kg of midazolam will be given to ensure amnesia in case of inadvertent awareness. If the patient's HR or MAP increases by more than 20% above preoperative values, the propofol concentration will be increased by 0.3 mcg/ml. If intraoperative awareness is suspected, indicated by lacrimation or spontaneous respiration, an additional 0.03 mg/kg midazolam and 0.2 mg/kg esketamine will be administered. Rocuronium bromide will be given at 0.6 mg/kg LBW for intubation. Dosing of intravenous fluids, blood transfusions, vasopressors, and inotropes will be managed by the attending anaesthesiologist.

Interventions

Multimodal monitoring DEVICE

The rSO2 will be maintained during surgery by ensuring appropriate haemoglobin concentration and DO2 at or above 85% of baseline. If rSO2 falls below this level, a DO2 optimisation protocol will be activated, confirming anaesthetic depth and maintaining SpO2 levels. If SVV exceeds 12%, a crystalloid bolus of 250 ml will be administered until SVV decreases or no further increases in SVI occur. Should SVV be below 12%, the PPV to SVV ratio will be assessed, with continued crystalloid administration warranted for a ratio over 0.7. SVRI will be evaluated, and if SVRI is below 1600 dynes·s·m²/cm⁵, a norepinephrine bolus will be administered. A noticeable increase in MAP (\>10%) will require a norepinephrine infusion to maintain MAP above 65 mmHg. If these measures do not suffice, CI will be monitored, and dobutamine will be infused if CI drops below 2.4 L/min/m². If rSO2 remains low after all interventions, adjustments to head position and increases in FiO2 or PEEP will be made.

Interventional

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

University hospital Dubrava

Zagreb, Croatia, 10040, Croatia

RECRUITING

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Related Links

• LiDCOrapid. LiDCO - Hemodynamic Monitoring for the entire patient pathway
• 17\. jamovi - open statistical software for the desktop and cloud

Study Officials

• Jasminka Peršec, M.D., PhD, Ass. Prof

  University Hospital Dubrava

  STUDY CHAIR

• Andrej Šribar, Assoc. Prof., MD, PhD

  University Hospital Dubrava

  STUDY CHAIR

Central Study Contacts

Marko Pražetina, MD

CONTACT

+385958150841; mprazetina1991@gmail.com

Helena Ostović, MD, PhD

CONTACT

+385 95 909 4007; helenaostovic@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intraoperative multimodal monitoring as a means in reducing the duration of mechanical ventilation in high-risk patients undergoing major abdominal procedures - a pilot study

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 14, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From June 1st, 2026 until December 31st, 2027
• Access Criteria: Individuals who submit a formal, written request will have their submissions evaluated by the Study Group, and permission will be granted accordingly.

Locations

CR (1)