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Plethysmography Variability Index as an Indicator of Adequacy of Preload

NCT01285622 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 77

Last updated 2021-04-05

No results posted yet for this study

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.

Conditions

  • Gynecological Surgery

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Principal Investigators

  • Rainer Lenhardt, MD · University of Louisville

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-01
Primary Completion
2012-01-31
Completion
2018-11-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01285622 on ClinicalTrials.gov