NCT02908256

Randomized Double-blind Comparison of Intraoperative Volume Replacement Determined by the Plethysmograph Variability Index (PVI) With That Determined by the Delta PP in the Digestive, Gynecological, Urological, and Abdominal Surgery and Their Impact on the Length of Stay

Completed NA Last updated 18 January 2018

What this trial tests

NA trial testing Geloplasma (PVI) in Abdomino-pelvic Surgery in 80 participants. Completed in 1 March 2016.

Timeline

1 April 2011

Primary endpoint
1 March 2016

1 March 2016

Quick facts

Lead sponsor	Brugmann University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	80
Start date	1 April 2011
Primary completion	1 March 2016
Estimated completion	1 March 2016

Drugs / interventions tested

• Geloplasma (PVI) — full drug profile →
• Geloplasma (delta PP) — full drug profile →

Conditions studied

• Abdomino-pelvic Surgery — all drugs for Abdomino-pelvic Surgery →

Sponsor

Brugmann University Hospital

Who can join

18 and older, any sex, with Abdomino-pelvic Surgery. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Length of hospital stay
  Time frame: average of 5 days

Sponsor's own description

An optimal intraoperative fluid replacement reduces the hospital stay, the admissions in the intensive care unit and the mortality rate after a major surgery.

Different criteria are used to guide the optimal vascular filling of a patient. Among the various monitoring for the last twenty years are parameters originating from the respiratory variations of the arterial pressure curves and the pulse oximetry.

On arterial curves, the Systolic Pressure Variation (SPV) is the difference between the maximum systolic pressure (DeltaUp) and the minimal one (DeltaDown).On the oxygen saturometry curves obtained with the Masimo Radical7, the plethysmographic variability index (PVI) corresponds to the formula (PImax-PImin/PImax X 100%) where PI corresponds to the quotient expressed in % between the pulsed infrared absorption signal and the continuous absorption signal.

It has been demonstrated that the dynamic indexes were better than the static indexes to determine the response to the vascular filling. A meta-analysis showed that the dynamic changes of the variables derived from the arterial pressure curve of patients under mechanic ventilation could predict the vascular filling responsiveness with a high specificity and sensibility. The same thing applies to the variables derived from the pulsed oxymetry curves.

Furthermore, monitoring and minimizing, through the vascular filling, the variations of the pulsated arterial pressure (delta PP) induced by the mechanic ventilation during a high risk surgery allows to reduce the postoperative complications and the hospital length of stay. This has not yet been proved for the non invasive parameters (IP and PVI).

The goal of this study is thus to compare a non invasive strategy (based on PVI) to an invasive strategy (based on the deltaPP) of perioperatory filling during abdomino-pelvic interventions (digestive, gynecologic, urologic), in order to test their equivalence and measure their impact in terms of hospital stay.

This record is linked to the NCT02709252 record and share the same cohort of patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pleth variability index versus pulse pressure variation for intraoperative goal-directed fluid therapy in patients undergoing low-to-moderate risk abdominal surgery: a randomized controlled trial.
   Coeckelenbergh S, Coeckelenbergh S, Delaporte A, Ghoundiwal D, et al · · 2019 · cited 16× · PMID 30851740 · DOI 10.1186/s12871-019-0707-9