Perioperative hemodynamic optimization using the photoplethysmography in colorectal surgery (the PANEX3 trial): study protocol for a randomized controlled trial

Marc-Olivier Fischer, Anne-Lise Fiant, Mariam Boutros, Frédéric Flais, Tzetan Filipov, Stéphane Debroczi, Léa Pasqualini, Toufiq Rhanem, Jean-Louis Gérard, Lydia Guittet, Jean-Luc Hanouz, Arnaud Alves, Jean-Jacques Parienti, PANEX3 study group, Marc-Olivier Fischer, Anne-Lise Fiant, Mariam Boutros, Frédéric Flais, Tzetan Filipov, Stéphane Debroczi, Léa Pasqualini, Toufiq Rhanem, Jean-Louis Gérard, Lydia Guittet, Jean-Luc Hanouz, Arnaud Alves, Jean-Jacques Parienti, PANEX3 study group

Abstract

Background: Photoplethysmography with a digital sensor (ClearSight, Edwards Lifesciences, Irvine, CA, USA) connected to a dedicated monitor (EV 1000, Edwards Lifesciences) was recently proposed for use in performing hemodynamic optimization during surgery. The objective of this study is to evaluate the effect of photoplethysmography on the incidence of postoperative complications compared with the conventional hemodynamic algorithm, which uses mean arterial pressure.

Methods/design: The hemodynamic optimization using photoplethysmography (PANEX3) trial is a monocentric, randomized, single-blind, controlled, two parallel arm, superiority trial, randomizing 160 patients with an intermediate risk of postoperative complications after colorectal surgery. Informed consent will be obtained from all participants. The hemodynamic optimization is conducted using a specified hemodynamic algorithm either with photoplethysmography (the photoplethysmography group) or with conventional mean arterial pressure (the control group). The anesthesiologist performed a 1:1 randomization the day before surgery using a scratch card, which is available 24/7. The randomization sequence is generated using permutated blocks. Both the patients and surgeons are blinded to the allocation group. The primary outcome is the incidence of at least one postoperative complication during the 30 days following surgery. Two independent experts, who were blinded to the group allocations, validate the complication for each patient using an a priori classification. The secondary outcomes are to study the total number of postoperative complications, the real length of hospital stays, and the postoperative mortality between each group.

Discussion: The PANEX3 trial is the first randomized controlled study conducted to investigate whether perioperative hemodynamic optimization using photoplethysmography during colorectal surgery could decrease the incidence of patients having at least one postoperative complication.

Trial registration: ClinicalTrials.gov Identifier: NCT02343601.

Keywords: Abdominal surgery; Anesthesiology; Hemodynamic; Plethysmography.

Figures

Fig. 1
Fig. 1
Consort diagram of the PANEX3 trial
Fig. 2
Fig. 2
Hemodynamic algorithm for the control group. *Norepinephrine after the failure of the use of ephedrine, which is defined by the use of 30 mg of ephedrine without the desired hemodynamic response. Norepinephrine: dosage began at 0.05 μg/kg/min and then was adjusted in steps of 0.05 μg/kg/min. MAP, mean arterial pressure
Fig. 3
Fig. 3
Hemodynamic algorithm for the photoplethysmography group. *Norepinephrine after the failure of the use of ephedrine, which is defined by the use of 30 mg of ephedrine without the desired hemodynamic response. Norepinephrine: dosage began at 0.05 μg/kg/min and then was adjusted in steps of 0.05 μg/kg/min. MAP, mean arterial pressure

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