Clinical trial NCT03009669: The Application of Pleth Variability Index in Continuous Monitoring the Volume Status of Intraoperative Patients
Official title: The Application of Pleth Variability Index in Continuous Monitoring Volume Status in Patients Undergoing Intestinal Tumor Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodynamic Monitoring
Keywords: pleth variability index
stroke volume variation
perfusion Index
intraoperative
intestinal tumor
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Guangzhou Panyu Central Hospital
First posted: 2017-01-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 patients undergoing elective intestinal tumor surgery were enrolled, ASAⅠ-Ⅲ,aged 18-65 years,BMI 18\~30kg/㎡.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the correlation of SVV and PVI
timeFrame: during the surgery
Secondary outcomes:
measure: stroke volume variability(SVV)
timeFrame: during the surgery
measure: pleth variability index(PVI)
timeFrame: during the surgery
measure: pleth index(PI)
timeFrame: during the surgery
measure: cardiac index(CI)
timeFrame: during the surgery
measure: stroke volume index(SVI)
timeFrame: during the surgery
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Shu HaiHua, doctor
role: STUDY_CHAIR
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