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

May 8, 2025 updated by: Ela Erdem Hıdiroglu, Ankara Etlik City Hospital

Comparison of Fluid Administered According to Plethysmographic Variability Index Versus Ideal Fluid Management in Laparoscopic Trendelenburg Surgeries

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • Ankara Etlik City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Study Population

Laparoscopic lower abdominal surgery (patients undergoing gynecological oncology and surgical oncology surgery)

Description

İnclusion Criteria:

  • between the ages of 18-80
  • patients with ASA score II III
  • Laparoscopic lower abdominal surgery (patients undergoing gynecological oncology and surgical oncology surgery)

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Massimo group
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.
Device: massimo group
masimo is a device for the continuous noninvasive measurement of arterial hemoglobin functional oxygen saturation (SpO2), pulse rate (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index).
Active Comparator: standart group
intraoperative fluid deficit is calculated according to the 4-2-1 rule by summing up the hourly basal fasting level, intraoperative losses depending on the degree of tissue trauma (1-2mlt/kg/h in small-sized surgeries, 2-4mlt/kg/h in medium-sized surgeries, 4-8mlt/kg/h in large-sized surgeries), blood losses, urine and losses from the nasogastric tube. Fluid is given in this way.
Other: standart group
intraoperative fluid deficit is calculated according to the 4-2-1 rule by summing up the hourly basal fasting level, intraoperative losses depending on the degree of tissue trauma (1-2mlt/kg/h in small-sized surgeries, 2-4mlt/kg/h in medium-sized surgeries, 4-8mlt/kg/h in large-sized surgeries), blood losses, urine and losses from the nasogastric tube. Fluid is given in this way.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PI (perfusion index)
Time Frame: ten minutes results before induction
arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate (PR) beats per minute, pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
ten minutes results before induction
PVI (pleth variability index)
Time Frame: ten minutes results before induction
arterial hemoglobin functional oxygen saturation % (SpO2, pulse rate (PR) beats per minute, pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
ten minutes results before induction
SPO2 (hemoglobin functional oxygen saturation)
Time Frame: ten minutes results before induction
arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate (PR) beats per minute, pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
ten minutes results before induction
PR (pulse rate beats per minute)
Time Frame: ten minutes results before induction
arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate (PR) beats per minute, pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
ten minutes results before induction
PI (perfusion index)
Time Frame: ten minutes when c02 insufflation is performed into the abdomen
arterial hemoglobin functional oxygen saturation (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
ten minutes when c02 insufflation is performed into the abdomen
PVI (pleth variability index)
Time Frame: ten minutes when c02 insufflation is performed into the abdomen
arterial hemoglobin functional oxygen saturation (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
ten minutes when c02 insufflation is performed into the abdomen
SPO2 (hemoglobin functional oxygen saturation)
Time Frame: ten minutes when c02 insufflation is performed into the abdomen
arterial hemoglobin functional oxygen saturation (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
ten minutes when c02 insufflation is performed into the abdomen
PR (pulse rate beats per minute)
Time Frame: t2(ten minutes when c02 insufflation is performed into the abdomen
arterial hemoglobin functional oxygen saturation (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
t2(ten minutes when c02 insufflation is performed into the abdomen
PI (perfusion index)
Time Frame: two hours during the surgery in the trendelenburg position
arterialhemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
two hours during the surgery in the trendelenburg position
PVI (pleth variability index)
Time Frame: two hours during the surgery in the trendelenburg position
arterialhemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
two hours during the surgery in the trendelenburg position
SPO2 (hemoglobin functional oxygen saturation)
Time Frame: two hours during the surgery in the trendelenburg position
arterialhemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
two hours during the surgery in the trendelenburg position
PR (pulse rate beats per minute)
Time Frame: two hours during the surgery in the trendelenburg position
arterialhemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
two hours during the surgery in the trendelenburg position
PI (perfusion index)
Time Frame: 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
five minute send of surgery
PVI (pleth variability index)
Time Frame: 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
five minute send of surgery
SPO2 (hemoglobin functional oxygen saturation)
Time Frame: 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
five minute send of surgery
PR (pulse rate beats per minute)
Time Frame: 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
five minute send of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Etlik City Hospital

Investigators

  • Principal Investigator: ELA ERDEM HIDIROGLU, Ankara Etlik City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Actual)

April 18, 2025

Study Completion (Actual)

May 5, 2025

Study Registration Dates

First Submitted

September 2, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2025

Last Update Submitted That Met QC Criteria

May 8, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ANKARA ETLİK 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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