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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 : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Rainer Lenhardt, University of Louisville

Study Description
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Brief Summary:

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
Gynecological Surgery

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Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Groups and Cohorts
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Group/Cohort
Gynecology patients
female subjects scheduled for elective robotic gynecological surgery under general anesthesia.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Hemodynamic measurements during surgery [ Time Frame: every 15 minutes ]
    blood pressure, cardiac index, pulse pressure variation


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
40 female subjects scheduled for elective robotic gynecological surgery under general anesthesia
Criteria

Inclusion Criteria:

  • female subjects scheduled for elective robotic gynecological surgery under general anesthesia

Exclusion Criteria:

  • atrial fibrillation
  • other significant arrhythmia (Lown grade 3 or higher
  • aortic regurgitation
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, Kentucky
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Rainer Lenhardt, MD University of Louisville
More Information
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Responsible Party: Rainer Lenhardt, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT01285622     History of Changes
Other Study ID Numbers: UofL IRB#10.0537
First Posted: January 28, 2011    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

Keywords provided by Rainer Lenhardt, University of Louisville:
Surgery; gynecological
Stroke volume