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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Abdomino-pelvic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PVI group

Monitoring of the PVI during the surgical intervention

Group Type EXPERIMENTAL

Geloplasma (PVI)

Intervention Type DRUG

In the PVI group, a filling solution (geloplasma) will be given as a bolus of 250 ml administered in 10 minutes if the PVI\>15% during more than 5 minutes. The bolus will be repeated if the PVI remains over 15%.

Delta PP group

Monitoring of the deltaPP during the surgical intervention

Group Type ACTIVE_COMPARATOR

Geloplasma (delta PP)

Intervention Type DRUG

In the delta PP group, a filling solution (geloplasma) will be given as a bolus of 250 ml administered in 10 minutes if the delta PP\> 13% during more than 5 minutes. The bolus will be repeated if the delta PP remains over 13%.

Interventions

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Geloplasma (PVI)

In the PVI group, a filling solution (geloplasma) will be given as a bolus of 250 ml administered in 10 minutes if the PVI\>15% during more than 5 minutes. The bolus will be repeated if the PVI remains over 15%.

Intervention Type DRUG

Geloplasma (delta PP)

In the delta PP group, a filling solution (geloplasma) will be given as a bolus of 250 ml administered in 10 minutes if the delta PP\> 13% during more than 5 minutes. The bolus will be repeated if the delta PP remains over 13%.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No