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

Not Applicable

Completed

• Conditions: Abdomino-pelvic Surgery
• Interventions: Drug: Geloplasma (PVI); Drug: Geloplasma (delta PP)

• Registration Number: NCT02908256
• Lead Sponsor: Brugmann University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Study First Submitted: 2016-09-16
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-20
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Abdominal-pelvic surgery (digestive, gynecologic, urologic) with laparotomy or laparoscopy
• Surgery duration superior to 1 hour

Exclusion Criteria

• ASA score of 4
• BMI > 35
• supraventricular arrythmia (isolated extrasystoles excepted)
• cardiac insufficiency (F.E < 25 %)
• severe peripheric vascular affections
• severe respiratory affections
• terminal renal insufficiency (creatine clear and < 30 mL/min)
• gelatin allergies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI group	Geloplasma (PVI)	Monitoring of the PVI during the surgical intervention
Delta PP group	Geloplasma (delta PP)	Monitoring of the deltaPP during the surgical intervention

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	average of 5 days

Secondary Outcome Measures

Name	Time	Method
length of stay in recovery room	up to 24 hours
EVA score	up to 72 hours	post surgery pain scoring
First time up	up to 72 hours	First time up/ first time sitting in a chair
number of anti-emetics administered	up to 72 hours