Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633510
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Fluid Administered According to PVI Versus Fluid Management in Laparoscopic Trendelenburg Surgeries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Fluid Administered According to Plethysmographic Variability Index Versus Ideal Fluid Management in Laparoscopic Trendelenburg Surgeries
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1-2mltkgh in minor surgeries 2-4mltkgh in medium surgeries 4-8mltkgh 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 patients 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 patients massimo PVI value is below 25 restrictive fluid therapy will be followed
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
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 patients 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 patients massimo PVI value is below 25 restrictive fluid therapy will be followed
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None