Comparison of Conventional Fluid Management Protocol With Targeted Pleth Variability Index (PVI) Monitoring Protocol During Total Abdominal Hysterectomy and Bilateral Salpingooferectomy Operation

Perioperative/Postoperative Complications Clinical Trial

Official title:

Comparison of Conventional Fluid Management Protocol With Targeted Pleth Variability Index (PVI) Monitoring Protocol During Total Abdominal Hysterectomy and Bilateral Salpingooferectomy Operation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04775576
• Other study ID #: 2020/514/172/4
• Status: Completed
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: July 12, 2021

Study information

• Verified date: July 2021
• Source: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to compare the volume management methods performed by using conventional method and PVI monitoring in intraoperative fluid treatment during bilateral salpingo-oophorectomy and total hysterectomy operation.

Description:

Intraoperative fluid management is very important in terms of postoperative organ perfusion and complications. While various complications such as acute renal failure, hypotension, arrhythmia, anastomotic leakage can be seen due to intraoperative hypovolemia; Hypervolemia can cause pulmonary edema, postoperative pneumonia, prolonged mechanical ventilation need, delayed wound healing, gastrointestinal system (GIS) edema and decreased intestinal motility.

Increasing the quality of intraoperative fluid therapy is a situation that may affect the morbidity and mortality of patients due to all these reasons.

Conventional fluid management is widely used in clinical practice. In this method, the fluid need of the patient is decided according to pulse, arterial blood pressure, central venous pressure, urine output and clinical condition. In the targeted fluid therapy method, besides static parameters such as pulse, arterial blood pressure, central venous pressure; Dynamic parameters such as Stroke volume variability (SVV), pulse pressure variability (PPV), pleth variability index (PVI), continuous hemoglobin (SpHb) are also used noninvasively. Studies related to SpHb, which provides noninvasive continuous hemoglobin monitoring in accordance with pulse oximetry, show that there is a decrease in blood product transfusion compared to cases managed with conventional laboratory follow-up.

Our primary goal is to compare the control group (conventional fluid management) with the PVI group (Pleth Variability Index and SpHb guided targeted fluid management) protocol.

For this purpose, we aim to compare the amount of crystalloids and blood products, blood lactate, serum creatinine and electrolyte levels applied in the intraoperative period as a result of both protocols. Our secondary aim will be to compare the length of stay in the hospital.

The study is planned as a single center, prospective, randomized controlled clinical study. It was aimed to evaluate fluid therapy during elective total abdominal hysterectomy and bilateral salpingooferectomy operation. Before the operation, patients will be divided into 2 groups randomly. For randomization, the automatic system on the randomization.com website will be used. All patients included in the study will be premedicated with 1mg of midazolam after monitoring with pulse, non-invasive blood pressure, oxygen saturation. Then, invasive arterial cannulation will be applied and continuous blood pressure monitoring will be done. In the PVI group, non-invasive PVI and SpHb monitoring will also be performed from the other upper extremity without arterial cannulation. After two minutes of preoxygenation, anesthesia induction will be started. Anesthesia induction doses used routinely in our clinic include iv 2 mg / kg propofol, 0.6 mg / kg rocuronium and 2 μg / kg fentanyl. Sevoflurane will be administered by inhalation during anesthesia maintenance after tracheal intubation. Initially, all patients will be given 250 ml intravenous crystalloid. Then 8-10 ml / kg / hour iv fluid maintenance will be started for the control group. If the mean arterial pressure (MAP) is <65 mmHg or the decrease in MAP is more than 20%, 250 ml iv colloid will be applied. If the decrease in MAP continues despite the colloid bolus or if the MAP is below 65 mmHg, noradrenaline infusion will be started. Patients in the PVI group will be started on maintenance fluid therapy at 2-3 ml / kg / hour. In addition to standard monitoring, if PVI is <13% and OAB≥65mmHg in measurements made with PVI, current fluid therapy will continue. If PVI is <13% and MAP <65 mmHg, noradrenaline infusion will be started. If PVI is> 13% and OAB≥65 mmHg, 250 ml iv colloid bolus will be administered, and iv colloid bolus will be continued until the PVI is <13% in the 5-minute follow-ups. If PVI> 13% and MAP <65 mmHg, patients should receive 250 ml i.v. colloid infusion will be given, if MAP <65mmHg continues in 5 minutes follow-up, 250 ml i.v. Colloid and noradrenaline infusion will be started and repeated until the OAB≥65 mmHg and PVI <13%. The decision to transfuse in both groups will be taken under the guidance of the European Society of Anesthesia (ESA) perioperative bleeding management guidelines. In the control group, hemorrhage will be monitored with laboratory Hb values, while SpHb and laboratory Hb values will be evaluated together in the PVI group.

Patients in the ASA1-2-3 risk group who will undergo elective total abdominal hysterectomy and bilateral salpingo-oophorectomy under general anesthesia, between the ages of 18-65, will be included in this study. The study will be conducted with 80 people.

In both groups, continuous arterial blood pressure, heart rate, oxygen saturation and arterial blood gas, lactate concentration at hourly intervals, hemoglobin, hematocrit, serum urea, creatinine, sodium, potassium, chlorine values, hospital stay, hourly intervals, intraoperative hourly and postoperatively 24 hours later, The amount of crystalloids and blood products used intraoperatively, postoperative volume dependent complications and their frequency will be evaluated.

The study will be conducted by anesthesiologists in the operating rooms located in the central campus of our hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 12, 2021
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Total abdominal hysterectomy and bilateral salpingooferectomy operation is planned Patients in the ASA 1-2-3 group

Exclusion Criteria:

Under 18 years old Severe cardiac arrhythmia Ejection fraction = 30% Acute and / or chronic renal failure Patients who need more than 8ml / kg tidal volume due to advanced stage COPD

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Hypervolemia
• Hypotension
• Intraoperative Complications
• Intraoperative Hypotension
• Perioperative/Postoperative Complications
• Postoperative Complications
• Volume Overload

Intervention

Other:
• Pleth Variability Index
Conventional fluid management is widely used in clinical practice. In this method, the fluid need of the patient is decided according to pulse, arterial blood pressure, central venous pressure, urine output and clinical condition. In the targeted fluid therapy method, besides static parameters such as pulse, arterial blood pressure, central venous pressure; Dynamic parameters such as Stroke volume variability (SVV), pulse pressure variability (PPV), pleth variability index (PVI), continuous hemoglobin (SpHb) are also used noninvasively.
• Conventional fluid theraphy
8-10 ml / kg / hour iv fluid maintenance will be started for the control group. If the mean arterial pressure (MAP) is <65 mmHg or the decrease in MAP is more than 20%, 250 ml iv colloid will be applied. If the decrease in MAP continues despite the colloid bolus or if the MAP is below 65 mmHg, noradrenaline infusion will be started.
• Anesthesia method
All patients included in the study will be premedicated with 1mg of midazolam after monitoring with pulse, non-invasive blood pressure, oxygen saturation. Then, invasive arterial cannulation will be applied and continuous blood pressure monitoring will be done. In the PVI group, non-invasive PVI and SpHb monitoring will also be performed from the other upper extremity without arterial cannulation. After two minutes of preoxygenation, anesthesia induction will be started. Anesthesia induction doses used routinely in our clinic include iv 2 mg / kg propofol, 0.6 mg / kg rocuronium and 2 µg / kg fentanyl. Sevoflurane will be administered by inhalation during anesthesia maintenance after tracheal intubation.

Locations

Country	Name	City	State
Turkey	Kartal Dr. Lutfi Kirdar City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Arieff AI. Fatal postoperative pulmonary edema: pathogenesis and literature review. Chest. 1999 May;115(5):1371-7. Review. — View Citation

Doherty M, Buggy DJ. Intraoperative fluids: how much is too much? Br J Anaesth. 2012 Jul;109(1):69-79. doi: 10.1093/bja/aes171. Epub 2012 Jun 1. Review. — View Citation

Holte K, Sharrock NE, Kehlet H. Pathophysiology and clinical implications of perioperative fluid excess. Br J Anaesth. 2002 Oct;89(4):622-32. Review. — View Citation

Miller RD, Ward TA, Shiboski SC, Cohen NH. A comparison of three methods of hemoglobin monitoring in patients undergoing spine surgery. Anesth Analg. 2011 Apr;112(4):858-63. doi: 10.1213/ANE.0b013e31820eecd1. Epub 2011 Mar 8. — View Citation

Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology. 2005 Jul;103(1):25-32. — View Citation

Raikhel M. Accuracy of noninvasive and invasive point-of-care total blood hemoglobin measurement in an outpatient setting. Postgrad Med. 2012 Jul;124(4):250-5. doi: 10.3810/pgm.2012.07.2584. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare the control group (conventional fluid management) with the PVI group (Pleth Variability Index and SpHb guided targeted fluid management) protocol.	compare the amount of crystalloids,colloids and blood products, blood lactate, serum creatinine and electrolyte levels applied in the intraoperative period as a result of both protocols.	0-180 minute
Secondary	Postoperative length of stay in hospital	Evaluation of postoperative hospital stay in both groups	24 hours
Secondary	Postoperative kidney injury	Present of postoperative kidney injury/failure	24 hours
Secondary	Postoperative Lung complications	Present of hypervolemia related lung edema	24 hours