Plethysmography Variability Index as an Indicator of Adequacy of Preload

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT01285622
First received: January 25, 2011
Last updated: November 12, 2012
Last verified: November 2012
  Purpose

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
Gynecological Surgery

Study Type: Observational
Study Design: 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

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Change in Hemodynamic measurements during surgery [ Time Frame: every 15 minutes ] [ Designated as safety issue: No ]
    blood pressure, cardiac index, pulse pressure variation


Secondary Outcome Measures:
  • Change in Forearm - fingertip temperature during surgery [ Time Frame: Every 15 minutes during surgery ] [ Designated as safety issue: No ]
    Forearm - fingertip temperature gradients will be measured by Mon-a-thermometer (Mallinckrodt Medical, Inc. St. Louis, MO) and disposable Mon-a-therm thermocouples.


Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gynecology patients
female subjects scheduled for elective robotic gynecological surgery under general anesthesia.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01285622     History of Changes
Other Study ID Numbers: UofL IRB#10.0537
Study First Received: January 25, 2011
Last Updated: November 12, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014