An interventional study of Pleth Variability Index and Conventional fluid theraphy in Intraoperative Hypotension, Intraoperative Complications and Hypervolemia, sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-13.
Sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital · Not applicable, Interventional, and Other
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.
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 78 is below the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Dr. Lutfi Kirdar Kartal Training and Research Hospital is the lead sponsor of 76 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
This group will have fluid theraphy due to conventional methods. The participants in this group will have 8-10 ml/kg/hour cristalloid infusion. 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.
Other: Conventional fluid theraphy · Other: Anesthesia method
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%.
Other: Pleth Variability Index · Other: Anesthesia method
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.
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.
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.
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.
Time frame: 0-180 minute
Postoperative length of stay in hospital
Evaluation of postoperative hospital stay in both groups
Time frame: 24 hours
Postoperative kidney injury
Present of postoperative kidney injury/failure
Time frame: 24 hours
Postoperative Lung complications
Present of hypervolemia related lung edema
Time frame: 24 hours
Plan to share: Yes
Supporting information: Study protocol, Csr
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Dr. Lutfi Kirdar Kartal Training and Research Hospital