Fluid Administered According to PVI Versus Fluid Management in Laparoscopic Trendelenburg Surgeries

Not Applicable

Completed

• Conditions: Fluid Overload Without Edema
• Interventions: Device: massimo

• Registration Number: NCT06633510
• Lead Sponsor: Ankara Etlik City Hospital

Brief Summary

Investigating the ideal fluid management in Trendelenburg positions during lower abdominal laparoscopic surgeries in gynecological oncology and surgical oncology patients

Detailed Description

Laparoscopic lower abdominal surgeries include carbon dioxide (CO2) insufflation and an advanced Trendelenburg position with the head down. Increased intra-abdominal pressure can reduce cardiac index and cause changes in total body fluid balance. However, the head down Trendelenburg position increases intracranial pressure and preload. According to traditional fluid management, intraoperative fluid deficit is calculated according to the 4-2-1 rule, by summing up hourly basal fasting level, intraoperative losses due to degree of tissue trauma (1-2mlt/kg/h in minor surgeries, 2-4mlt/kg/h in medium surgeries, 4-8mlt/kg/h in major surgeries), blood losses, urine and losses from nasogastric tube.

Preservation of intravascular volume and thus provision of hemodynamic stability are among the factors affecting postoperative morbidity and mortality. Some studies have shown that standard fluid therapy is more than necessary. Current guidelines recommend more restrictive approaches by ensuring hemodynamic stability. Masimo, which we also use routinely in our clinic, is a device designed for continuous noninvasive monitoring of arterial hemoglobin functional oxygen saturation (SpO2), pulse rate (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values. In our study, in the individualization of the recommended target-oriented restrictive fluid therapy in major surgeries, by comparing the calculated fluid amount with traditional fluid management with PVI values (PVI is evaluated between 0-100.

Normavolemia 15-25 low fluid responsiveness \<15 high fluid responsiveness \>25) and when the patient's massimo pvi score is \>25, 300cc bolus fluid will be administered and fluid will be loaded at an average speed and the PVI value will be reduced below 25. When the patient's massimo PVI value is below 25, restrictive fluid therapy will be followed.(A crystalloid fluid infusion of 2 mL/kg was administered to the patients.)

The aim was to investigate the ideal fluid management in Trendelenburg positions in lower abdominal laparoscopic surgeries performed in gynecological oncology and surgical oncology patients.

Study Timeline

• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-10-08
• Study First Posted: 2024-10-09
• Study Start: 2024-10-15
• Primary Completion: 2025-04-18
• Status Verified: 2025-05
• Study Completion: 2025-05-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

• ASA score IV
• Patients with heart failure and chronic kidney disease
• Patients who did not agree to participate in the study
• Cases that started laparoscopically and converted to laparotomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Massimo group	massimo	The patient is not given fluids until the Massimo PVI score is \>25, a 300 cc fluid bolus is given when the PVI is above 25, and fluid loading is performed at an average rate until the PVI falls below 25. If the patient's Massimo PVI is below 25, restrictive fluid therapy is applied.

Primary Outcome Measures

Name	Time	Method
PI (perfusion index)	five minute send of surgery	arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
PVI (pleth variability index)	five minute send of surgery	arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
SPO2 (hemoglobin functional oxygen saturation)	five minute send of surgery	arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
PR (pulse rate beats per minute)	five minute send of surgery	arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

Trial Locations

Locations (1)

Ankara Etlik City Hospital; 🇹🇷 Ankara, Turkey