Plethysmography Variability Index as an Indicator of Adequacy of Preload
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|ClinicalTrials.gov Identifier: NCT01285622|
Recruitment Status : Suspended (Unable to receive funding)
First Posted : January 28, 2011
Last Update Posted : June 28, 2017
The investigators propose a prospective observational trial. The investigators plan to enroll 40 female subjects scheduled for elective robotic gynecological surgery under general anesthesia. Hemodynamic data will be recorded at the following intervals: after induction of anesthesia (Baseline), after initiation of pneumoperitoneum, after positioning the patient in Trendelenburg position, and every 15 minutes thereafter. At the end of surgery measurements will be recorded after reversal of Trendelenburg position and after deflation of the peritoneum.
Forearm - fingertip temperature gradients will be measured by Mon-a-thermometer (Mallinckrodt Medical, Inc. St. Louis, MO) and disposable Mon-a-therm thermocouples. Vasoconstriction will be identified when forearm - fingertip temperature gradient is ≥ 00C and PI <1.
Intra-abdominal pressures will be recorded during each measurement of hemodynamic parameters. Trendelenburg position will be measured with an angle ruler.
The aim of our study is to test the hypothesis that stroke volume will drop significantly after initiation of pneumoperitoneum and that it will increase after placement in Trendelenburg position in patients undergoing robotic gynecological procedures. Secondly, the investigators will test the hypothesis that PVI changes correlate with changes in stroke volume and pulse pressure variation (PPV) and can predict an increase in stroke volume after a fluid bolus. The third hypothesis is that delta PVI is independent of the vaso-status of precapillaries at the measured site.
|Condition or disease|
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|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Cardiac Output Changes and Evaluation of Plethysmography Variability Index (PVI) as an Indicator of Adequacy of Preload in Women Undergoing Robotic Surgery|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
female subjects scheduled for elective robotic gynecological surgery under general anesthesia.
- Change in Hemodynamic measurements during surgery [ Time Frame: every 15 minutes ]blood pressure, cardiac index, pulse pressure variation
- Change in Forearm - fingertip temperature during surgery [ Time Frame: Every 15 minutes during surgery ]Forearm - fingertip temperature gradients will be measured by Mon-a-thermometer (Mallinckrodt Medical, Inc. St. Louis, MO) and disposable Mon-a-therm thermocouples.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285622
|United States, Kentucky|
|University of Louisville Hospital|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Rainer Lenhardt, MD||University of Louisville|