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NCT01285622 · ClinicalTrials.gov registry record
Plethysmography Variability Index as an Indicator of Adequacy of Preload
A clinical trial, sponsored by University of Louisville.
- Completed
- Registry status
- 77
- Enrollment target
NCT01285622: Completed study, sponsored by University of Louisville.
NCT01285622 is a clinical trial that has completed, run by University of Louisville. The registered enrollment target is 77 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01285622 has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- 77 participants
- Enrollment target
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.
Primary Outcome
blood pressure, cardiac index, pulse pressure variation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2011-01-01 |
| Est. Completion | 2018-11-28 |
What the finished NCT01285622 record still lists
NCT01285622 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 77 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01285622 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01285622 about?
NCT01285622 is a clinical study titled "Plethysmography Variability Index as an Indicator of Adequacy of Preload". 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), afte...
What is the current status of trial NCT01285622?
This trial is currently completed. The enrollment target is 77 participants. The study started on 2011-01-01. Estimated completion is 2018-11-28.
Who is sponsoring clinical trial NCT01285622?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
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