Evidence map›Paper›PMID 27004412›Full record

Trial reportTrials2016

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 and 4 more

3 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.3field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02343601 phase3completednot on this map

Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery : A Randomized Controlled Study

TypeinterventionalSponsorUniversity Hospital, CaenRan2014 to 2016Enrolled160ConditionsPolyp of Large Intestine, Colorectal Neoplasms, Crohn DiseaseArmsPhotoplethysmography
NCT05035537 nacompletednot on this mapstarted 2018, after this paper: background citation

Hemodynamic Optimization with Perioperative Gold Directed Therapy (PGDT) in Kidney Transplant

TypeinterventionalSponsorIRCCS Azienda Ospedaliero-Universitaria di BolognaRan2018 to 2023Enrolled181ConditionsKidney Transplant, ComplicationsArmsPGDT
NCT05394896 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Hypotension Prediction With HPI Algorithm During Decessed-donor Kidney Transplant: an Explorative, Monocentric, RCT

TypeinterventionalSponsorIRCCS Azienda Ospedaliero-Universitaria di BolognaRan2022 to 2024Enrolled46ConditionsHypotension During Surgery, Kidney Transplant, ComplicationsArmsACUMEN (Edwards Lifesciences, Irvine, USA), Invasive Blood Pressure
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 2 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 2 institutions in 1 country.

Marc-Olivier FischerPôle Réanimations Anesthésie SAMU/SMUR, CHU de Caen, Avenue de la Côte de Nacre, CS 30001, F-14000, Caen, France. marcolivierfischer@yahoo.fr.
Anne-Lise FiantPôle Réanimations Anesthésie SAMU/SMUR, CHU de Caen, Avenue de la Côte de Nacre, CS 30001, F-14000, Caen, France.
Mariam BoutrosPôle Réanimations Anesthésie SAMU/SMUR, CHU de Caen, Avenue de la Côte de Nacre, CS 30001, F-14000, Caen, France.
Frédéric FlaisPôle Réanimations Anesthésie SAMU/SMUR, CHU de Caen, Avenue de la Côte de Nacre, CS 30001, F-14000, Caen, France.
Tzetan FilipovPôle Réanimations Anesthésie SAMU/SMUR, CHU de Caen, Avenue de la Côte de Nacre, CS 30001, F-14000, Caen, France.
Stéphane DebrocziPôle Réanimations Anesthésie SAMU/SMUR, CHU de Caen, Avenue de la Côte de Nacre, CS 30001, F-14000, Caen, France.
Léa PasqualiniPôle Réanimations Anesthésie SAMU/SMUR, CHU de Caen, Avenue de la Côte de Nacre, CS 30001, F-14000, Caen, France.
Toufiq RhanemPôle Réanimations Anesthésie SAMU/SMUR, CHU de Caen, Avenue de la Côte de Nacre, CS 30001, F-14000, Caen, France.
Jean-Louis GérardPôle Réanimations Anesthésie SAMU/SMUR, CHU de Caen, Avenue de la Côte de Nacre, CS 30001, F-14000, Caen, France.
Lydia GuittetDepartment of Public Health, CHU de Caen, Avenue de la Côte de Nacre, CS 30001, F-14000, Caen, France.
Jean-Luc HanouzPôle Réanimations Anesthésie SAMU/SMUR, CHU de Caen, Avenue de la Côte de Nacre, CS 30001, F-14000, Caen, France.
Arnaud AlvesService de chirurgie digestive, CHU de Caen, Avenue de la Côte de Nacre, CS 30001, F-14000, Caen, France.
Jean-Jacques ParientiDepartment of Biostatistics and Clinical Research, CHU de Caen, Avenue de la Côte de Nacre, CS 30001, F-14000, Caen, France.
PANEX3 study group
Centre Hospitalier Universitaire de Caen Normandie · FRInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPhotoplethysmography 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/

designThe 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 registrationClinicalTrials.gov Identifier: NCT02343601.

Indexed as

Digestive System Surgical ProceduresHemodynamicsPhotoplethysmographyAlgorithmsArterial PressureClinical ProtocolsColonFranceHumansMonitoring, IntraoperativePostoperative ComplicationsPredictive Value of TestsRectumResearch DesignRisk FactorsSignal Processing, Computer-AssistedAbdominal surgeryAnesthesiologyHemodynamicPlethysmography

Identifiers

PMID27004412
PMCPMC4804484
OpenAlexW2307039450

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.