The Application of Pleth Variability Index in Continuous Monitoring the Volume Status of Intraoperative Patients

• Conditions: Hemodynamic Monitoring

• Registration Number: NCT03009669
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-30
• Study First Submitted QC: 2017-01-03
• Last Update Submitted: 2017-01-03
• Study First Posted: 2017-01-04
• Last Update Posted: 2017-01-04
• Primary Completion: 2017-07
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients undergoing elective intestinal tumor surgery
• American Society of Anesthesiologists (ASA) physical status of grade I-Ⅲ
• Aged 18-65 years
• BMI 18~30kg/㎡

Exclusion Criteria

• Patients under 18 years or above 65 years
• patients with severe aortic regurgitation
• patients with permanent cardiac arrhythmias
• patients with intra-aortic balloon pump
• patients with severe pulmonary disease
• patients undergoing emergency surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the correlation of SVV and PVI	during the surgery	SVV and PVI were recorded while after the induction of anesthesia(T1),making surgical incision(T2),performing intestinal anastomosis(T3) and closing the abdominal incision(T4). We calculate the correlation of SVV and PVI using Pearson Correlation Analysis at different time points.

Secondary Outcome Measures

Name	Time	Method
pleth index(PI)	during the surgery	pleth index(PI) in percentage.Record the date of PI while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4).Compare the differences of PI between the time points.
cardiac index(CI)	during the surgery	cardiac index(CI) in L•min-1•m-2.Record the date of CI while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4).Compare the differences of CI between the time points.
stroke volume index(SVI)	during the surgery	(SVI) in ml•m-2.Record the date of SVI while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4).Compare the differences of SVI between the time points.
stroke volume variability(SVV)	during the surgery	stroke volume variability(SVV) in percentage.Record the date of SVV while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4).Compare the differences of SVV between the time points.
pleth variability index(PVI)	during the surgery	pleth variability index(PVI) in percentage.Record the date of PVI while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4).Compare the differences of PVI between the time points.