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The OPVI trial - perioperative hemodynamic optimization using the plethysmographic variability index in orthopedic surgery: study protocol for a multicenter randomized controlled trial.

Fischer MO, Daccache G, Lemoine S, Tavernier B, Compère V, Hulet C, Bouchakour CE, Canevet C, Gérard JL, Guittet L, Lorne E, Hanouz JL, Parienti JJ - Trials (2015)

Bottom Line: Recently, the plethysmographic variability index (PVI) was described as a simplified alternative, using plug-and-play noninvasive technology, but its clinical utility remains to be established.Patients and surgeons, but not anesthesiology staff, were blinded to the allocation group.Secondary outcome measures are theoretical length of hospital stay, determined using a dedicated discharge-from-hospital checklist, postoperative arterial lactate level in the recovery room, postoperative troponin level, presence of serious postoperative cardiac complications, and postoperative acute kidney insufficiency.

View Article: PubMed Central - PubMed

Affiliation: Pôle Réanimations Anesthésie SAMU/SMUR, CHU de Caen, Avenue de la Côte de Nacre, CS 30001, F-14 000, Caen, France. fischer-mo@chu-caen.fr.

ABSTRACT

Background: Hemodynamic optimization during surgery is of major importance to decrease postoperative morbidity and length of hospital stay. However, conventional cardiac output monitoring is rarely used at the bedside. Recently, the plethysmographic variability index (PVI) was described as a simplified alternative, using plug-and-play noninvasive technology, but its clinical utility remains to be established.

Methods/design: The hemodynamic optimization using the PVI (OPVI) trial is a multicenter randomized controlled two-arm trial, randomizing 440 patients at intermediate risk of postoperative complications after orthopedic surgery. Hemodynamic optimization was conducted using either the PVI (PVI group) or conventional mean arterial pressure (control group). The anesthesiologist performed the randomization the day before surgery using an interactive web response system, available 24 hours a day, 7 days a week. The randomization sequence was generated using permutated blocks and stratified by center and type of surgery (knee or hip arthoplasty). Patients and surgeons, but not anesthesiology staff, were blinded to the allocation group. The primary outcome measure is the length of hospital stay following surgery. The attending surgeon, who was blinded to group assessment, determined hospital discharge. Secondary outcome measures are theoretical length of hospital stay, determined using a dedicated discharge-from-hospital checklist, postoperative arterial lactate level in the recovery room, postoperative troponin level, presence of serious postoperative cardiac complications, and postoperative acute kidney insufficiency.

Discussion: The OPVI trial is the first multicenter randomized controlled study to investigate whether perioperative hemodynamic optimization using PVI during orthopedic surgery could decrease the length of hospital stay and postoperative morbidity.

Trial registration: ClinicalTrials.gov NCT02207296 .

No MeSH data available.


Related in: MedlinePlus

Hemodynamic algorithm for the PVI group. *Norepinephrine after failure of the use of ephedrine defined by the use of 30 mg of ephedrine without desired hemodynamic response. Norepinephrine: dosage begins at 0.05 μg/(kg min), and is then adjusted in steps of 0.05 μg/(kg min). IV, intravenous; IVD, intravenous drip; MAP, mean arterial pressure; PVI, plethysmographic variability index
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Fig3: Hemodynamic algorithm for the PVI group. *Norepinephrine after failure of the use of ephedrine defined by the use of 30 mg of ephedrine without desired hemodynamic response. Norepinephrine: dosage begins at 0.05 μg/(kg min), and is then adjusted in steps of 0.05 μg/(kg min). IV, intravenous; IVD, intravenous drip; MAP, mean arterial pressure; PVI, plethysmographic variability index

Mentions: In the PVI group (Fig. 3), the hemodynamic targets are both the PVI and the mean arterial pressure: the fluid challenge prescription depends on a PVI value > 13 %, according to a previous study [13], while vasopressor use depends on a mean arterial pressure < 65 mmHg.Fig. 3


The OPVI trial - perioperative hemodynamic optimization using the plethysmographic variability index in orthopedic surgery: study protocol for a multicenter randomized controlled trial.

Fischer MO, Daccache G, Lemoine S, Tavernier B, Compère V, Hulet C, Bouchakour CE, Canevet C, Gérard JL, Guittet L, Lorne E, Hanouz JL, Parienti JJ - Trials (2015)

Hemodynamic algorithm for the PVI group. *Norepinephrine after failure of the use of ephedrine defined by the use of 30 mg of ephedrine without desired hemodynamic response. Norepinephrine: dosage begins at 0.05 μg/(kg min), and is then adjusted in steps of 0.05 μg/(kg min). IV, intravenous; IVD, intravenous drip; MAP, mean arterial pressure; PVI, plethysmographic variability index
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4634899&req=5

Fig3: Hemodynamic algorithm for the PVI group. *Norepinephrine after failure of the use of ephedrine defined by the use of 30 mg of ephedrine without desired hemodynamic response. Norepinephrine: dosage begins at 0.05 μg/(kg min), and is then adjusted in steps of 0.05 μg/(kg min). IV, intravenous; IVD, intravenous drip; MAP, mean arterial pressure; PVI, plethysmographic variability index
Mentions: In the PVI group (Fig. 3), the hemodynamic targets are both the PVI and the mean arterial pressure: the fluid challenge prescription depends on a PVI value > 13 %, according to a previous study [13], while vasopressor use depends on a mean arterial pressure < 65 mmHg.Fig. 3

Bottom Line: Recently, the plethysmographic variability index (PVI) was described as a simplified alternative, using plug-and-play noninvasive technology, but its clinical utility remains to be established.Patients and surgeons, but not anesthesiology staff, were blinded to the allocation group.Secondary outcome measures are theoretical length of hospital stay, determined using a dedicated discharge-from-hospital checklist, postoperative arterial lactate level in the recovery room, postoperative troponin level, presence of serious postoperative cardiac complications, and postoperative acute kidney insufficiency.

View Article: PubMed Central - PubMed

Affiliation: Pôle Réanimations Anesthésie SAMU/SMUR, CHU de Caen, Avenue de la Côte de Nacre, CS 30001, F-14 000, Caen, France. fischer-mo@chu-caen.fr.

ABSTRACT

Background: Hemodynamic optimization during surgery is of major importance to decrease postoperative morbidity and length of hospital stay. However, conventional cardiac output monitoring is rarely used at the bedside. Recently, the plethysmographic variability index (PVI) was described as a simplified alternative, using plug-and-play noninvasive technology, but its clinical utility remains to be established.

Methods/design: The hemodynamic optimization using the PVI (OPVI) trial is a multicenter randomized controlled two-arm trial, randomizing 440 patients at intermediate risk of postoperative complications after orthopedic surgery. Hemodynamic optimization was conducted using either the PVI (PVI group) or conventional mean arterial pressure (control group). The anesthesiologist performed the randomization the day before surgery using an interactive web response system, available 24 hours a day, 7 days a week. The randomization sequence was generated using permutated blocks and stratified by center and type of surgery (knee or hip arthoplasty). Patients and surgeons, but not anesthesiology staff, were blinded to the allocation group. The primary outcome measure is the length of hospital stay following surgery. The attending surgeon, who was blinded to group assessment, determined hospital discharge. Secondary outcome measures are theoretical length of hospital stay, determined using a dedicated discharge-from-hospital checklist, postoperative arterial lactate level in the recovery room, postoperative troponin level, presence of serious postoperative cardiac complications, and postoperative acute kidney insufficiency.

Discussion: The OPVI trial is the first multicenter randomized controlled study to investigate whether perioperative hemodynamic optimization using PVI during orthopedic surgery could decrease the length of hospital stay and postoperative morbidity.

Trial registration: ClinicalTrials.gov NCT02207296 .

No MeSH data available.


Related in: MedlinePlus