Abdomino-pelvic Surgery Clinical Trial
Official title:
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
| Verified date | January 2018 |
| Source | Brugmann University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Brugmann University Hospital |
Bundgaard-Nielsen M, Holte K, Secher NH, Kehlet H. Monitoring of peri-operative fluid administration by individualized goal-directed therapy. Acta Anaesthesiol Scand. 2007 Mar;51(3):331-40. Review. — View Citation
Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. Epub 2008 Jun 2. — View Citation
Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da. Review. — View Citation
Michard F, Lopes MR, Auler JO Jr. Pulse pressure variation: beyond the fluid management of patients with shock. Crit Care. 2007;11(3):131. — View Citation
Zimmermann M, Feibicke T, Keyl C, Prasser C, Moritz S, Graf BM, Wiesenack C. Accuracy of stroke volume variation compared with pleth variability index to predict fluid responsiveness in mechanically ventilated patients undergoing major surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61. doi: 10.1097/EJA.0b013e328335fbd1. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Length of hospital stay | average of 5 days | ||
| Secondary | EVA score | post surgery pain scoring | up to 72 hours | |
| Secondary | number of anti-emetics administered | up to 72 hours | ||
| Secondary | length of stay in recovery room | up to 24 hours | ||
| Secondary | First time up | First time up/ first time sitting in a chair | up to 72 hours |