Plethysmography Variability Index as an Indicator of Adequacy of Preload

NCT01285622 | Completed

• 1 other identifier: UofL IRB#10.0537
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecological Surgery

Keywords

Surgery; gynecological; Stroke volume

Outcome Measures

Primary Outcomes (1)

• Change in Hemodynamic measurements during surgery

  blood pressure, cardiac index, pulse pressure variation

  every 15 minutes

Secondary Outcomes (1)

• Change in Forearm - fingertip temperature during surgery

  Every 15 minutes during surgery

Study Arms (1)

Gynecology patients

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• atrial fibrillation
• other significant arrhythmia (Lown grade 3 or higher
• aortic regurgitation

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Study Officials

• Rainer Lenhardt, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: January 28, 2011
• Study Start: January 1, 2011
• Primary Completion: January 31, 2012
• Study Completion: November 28, 2018
• Last Updated: April 5, 2021

Record last verified: 2021-03

Locations

US (1)