Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02908256
Enrollment
80
Registered
2016-09-20
Start date
2011-04-30
Completion date
2016-03-31
Last updated
2018-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdomino-pelvic Surgery

Keywords

PVI, delta PP, vascular filling

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.

Interventions

DRUGGeloplasma (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%.

DRUGGeloplasma (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%.

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Length of hospital stayaverage of 5 days

Secondary

MeasureTime frameDescription
EVA scoreup to 72 hourspost surgery pain scoring
number of anti-emetics administeredup to 72 hours
length of stay in recovery roomup to 24 hours
First time upup to 72 hoursFirst time up/ first time sitting in a chair

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026