Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT03009669
Status:
UNKNOWN
Last Update Posted:
2017-01-04
First Post:
2016-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Application of Pleth Variability Index in Continuous Monitoring the Volume Status of Intraoperative Patients
Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
Organization:
Study Overview
Official Title:
The Application of Pleth Variability Index in Continuous Monitoring Volume Status in Patients Undergoing Intestinal Tumor Surgery
Status:
UNKNOWN
Status Verified Date:
2016-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the value of using pleth variability index(PVI) to monitor the patient's intra-operative volume status continuously by observing the application of stroke volume variation(SVV) and PVI and their correlation in patients undergoing intestinal tumor surgeries.
Detailed Description:
Objective: To assess the value of using PVI to monitor the patient's intra-operative volume status continuously by observing the application of stroke volume variation(SVV) and pleth variability index(PVI) and their correlation in patients undergoing intestinal tumor surgeries.
Methods: 50 patients undergoing elective intestinal tumor surgery were enrolled, ASAⅠ-Ⅲ, aged 18-65 years. After the induction of general anesthesia, cardiac index(CI), cardiac output(CO), stroke volume variability(SVV), stroke volume index(SVI) were monitored with Vigileo system, while pleth variability index(PVI) and perfusion index(PI) were monitored with Massion Radical 7 system. During the surgery, goal directed fluid therapy was conducted according to the data of CI、SVI and SVV. Heart rate(HR), mean arterial pressure(MAP), central venous pressure(CVP), CO, CI, SVI, SVV, PI, PVI were recorded while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4). And we calculate the correlation of SVV and PVI using Pearson Correlation Analysis at different time points.
Methods: 50 patients undergoing elective intestinal tumor surgery were enrolled, ASAⅠ-Ⅲ, aged 18-65 years. After the induction of general anesthesia, cardiac index(CI), cardiac output(CO), stroke volume variability(SVV), stroke volume index(SVI) were monitored with Vigileo system, while pleth variability index(PVI) and perfusion index(PI) were monitored with Massion Radical 7 system. During the surgery, goal directed fluid therapy was conducted according to the data of CI、SVI and SVV. Heart rate(HR), mean arterial pressure(MAP), central venous pressure(CVP), CO, CI, SVI, SVV, PI, PVI were recorded while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4). And we calculate the correlation of SVV and PVI using Pearson Correlation Analysis at different time points.
Study Oversight
Has Oversight DMC:
True
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?: