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Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality (OPTI-AGED)

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ClinicalTrials.gov Identifier: NCT02668250
Recruitment Status : Recruiting
First Posted : January 29, 2016
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:

With the increasing aging population demographics and life expectancies, the number of very elderly patients undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group.

Cardiac complications and postoperative pulmonary complications are equally prevalent and contribute similarly to morbidity, mortality, and length of hospital stay. Specific optimization strategy of general anesthesia has been tested in high-risk patients undergoing major surgery to improve outcomes.

Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly undergoing high risk surgery.


Condition or disease Intervention/treatment Phase
Coronary; Ischemic Arrhythmias, Cardiac Heart Failure Peripheral Vascular Diseases Dementia Stroke Pulmonary Disease, Chronic Obstructive Respiratory Insufficiency Alcoholism Cancer Diabetes Renal Insufficiency Procedure: OPTI-AGED Procedure: Usual Care Not Applicable

Detailed Description:

The population is expanding and aging. With the increasing aging population demographics and life expectancies, the number of very elderly patients (age ≥ 75) undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group. In 2010, patients aged 75 yrs and over represented only 2.1% of patients undergoing high risk surgery in France (PMSI database), but concentrated 27% of in-hospital deaths.

Cardiac complications and postoperative pulmonary complications are equally prevalent and contribute similarly to morbidity, mortality, and length of hospital stay. Specific optimization strategy of general anesthesia has been tested in high-risk patients undergoing major surgery to improve outcomes. Meta-analyses have demonstrated that goal directed hemodynamic therapy significantly reduced mortality and surgical complications in high-risk patients. A lung-protective ventilation strategy in high-risk patients undergoing major abdominal surgery was associated with improved clinical outcome. Retrospective studies indicated that a combination of excessive depth of anesthesia, hypotension and low anesthesia requirement resulted in increased mortality. These approaches of peroperative care remain discussed in the literature and have also to be incorporated in the common clinical practice. Moreover, few of these reviews performed a sensitive analysis in the elderly.

Whether a multi-parametric optimization strategy of anesthesia including several specific interventions will impact the short-term postoperative major morbidity and mortality in elderly is not known. The addition of depth of anesthesia monitoring to hemodynamic monitoring and goal directed hemodynamic therapy may improve tissue perfusion by reducing hemodynamic side effects of anesthetic agents, particularly in elderly where the therapeutic window of these agents is reduced. The effects of low protective ventilation may also by additive to the previous measures by reducing the perioperative build-up of oxygen debt. Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly undergoing high risk surgery.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The OPTI-AGED Study : Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality in Elderly Patients. A Randomized, Multicentre, Prospective Controlled Study
Actual Study Start Date : February 3, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: Experimental group : OPTI-AGED
The OPTI-AGED group will receive a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia.
Procedure: OPTI-AGED
OPTI-AGED is composed of a multi-parametric optimization strategy.

Active Comparator: Control Group :
The control group will not benefit from the OPTI-AGED intervention but patients will receive the usual care.
Procedure: Usual Care
Patients receive the usual care.




Primary Outcome Measures :
  1. Incidence of a major postoperative complication. [ Time Frame: Day 30 ]
    Major postoperative complications (acute kidney injury, acute myocardial infarction, heart failure, stroke, severe sepsis, septic shock, acute respiratory failure requiring noninvasive ventilation or intubation, delirium) will be reported in the source folder of the patients, and the mortality will be also focused. The goal of this study is to decrease this incidence.



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult patients aged 75 years and over,
  • presenting at least one of the following comorbidities: ischemic coronary disease; cardiac arrhythmia; congestive heart failure; peripheral vascular disease; dementia; stroke; chronic obstructive pulmonary disease; chronic respiratory failure; chronic alcohol abuse; active cancer; diabetes; chronic renal failure A comorbidity index will be measured by using the modified Charlson Comorbidity Index
  • undergoing elective and emergency surgeries including : femoral head fracture, major intraperitoneal abdominal surgery lasting > 90 min (excluding elective cholecystectomy, abdominal wall surgery), vascular surgery (excluding venous surgery and fistula creation)
  • Patient's or patient's relative signed consent form
  • Affiliation to French social assurance system

Exclusion Criteria:

  • Acute heart failure and acute coronary syndrome
  • Acute respiratory failure, pneumonia
  • Septic shock
  • Delirium
  • Acute stroke
  • Evolutive neuromuscular disorder
  • Thoracic surgery, combined abdominal and thoracic surgery
  • Surgery performed under exclusive regional anesthesia
  • Patients under tutorship or curatorship
  • Refusal to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668250


Contacts
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Contact: MOLLIEX Serge, MD (0)477120922 ext +33 serge.molliex@chu-st-etienne.fr
Contact: RANCON Florence, CRA (0)477829458 ext +33 florence.rancon@chu-st-etienne.fr

Locations
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France
CHU Amiens - Picardie Recruiting
Amiens, France
Contact: Emmanuel Lorne, MD         
Principal Investigator: Emmanuel Lorne, MD         
Sub-Investigator: Ghada Antoun, MD         
Sub-Investigator: Rachid Badaoui, MD         
Sub-Investigator: Alexandre Ntouba, MD         
CHU CAEN Recruiting
Caen, France
Contact: HANOUZ Jean-Luc, MD         
Principal Investigator: Jean-Luc HANOUZ, MD         
Sub-Investigator: Marc-Olivier Fischer, MD         
Sub-Investigator: Dorothée Radenac, MD         
Sub-Investigator: Georges Daccache, MD         
Sub-Investigator: Christophe Persyn, MD         
Sub-Investigator: Marion Zamparini, MD         
Sub-Investigator: Toufiq Rhanem, MD         
Chu Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: CONSTANTIN Jean-Michel, MD         
Principal Investigator: Emmanuel Futier, MD         
Sub-Investigator: Véronica Balaceanu, MD         
Sub-Investigator: Oana Cherbis, MD         
Sub-Investigator: Isabelle Curt, MD         
Sub-Investigator: Danielle Saurel, MD         
Sub-Investigator: Marie Vignaud, MD         
Sub-Investigator: Antoine Brandely, MD         
Sub-Investigator: Solène Paul, MD         
Sub-Investigator: Vladimir Leonenko, MD         
Chu Dijon Recruiting
Dijon, France, 21079
Contact: Belaid Bouhemad, MD         
Principal Investigator: Belaid Bouhemad, MD         
Sub-Investigator: Ophélie Dransart-Raye, MD         
Sub-Investigator: Nicolas Nowobilski, MD         
Médipôle Lyon - Villeurbanne Recruiting
Décines-Charpieu, France
Contact: Vincent Collange, MD         
Principal Investigator: Vincent Collange, MD         
Sub-Investigator: Mahieddine Haddad, MD         
Sub-Investigator: Sébastien Parent, MD         
Sub-Investigator: Olivier Ganne, MD         
Sub-Investigator: Romain Guyot, MD         
Chu Grenoble Recruiting
Grenoble 9, France, 38043
Principal Investigator: Pierre Bouzat, MD         
Sub-Investigator: Jules Greze, MD         
Sub-Investigator: Julien Brun, MD         
Sub-Investigator: Karine Berger, MD         
Sub-Investigator: Marion Berthet, MD         
Sub-Investigator: Caroline Machuron, MD         
Sub-Investigator: Lara Puthon, MD         
Sub-Investigator: Marion Taleb, MD         
Sub-Investigator: Pierluigi Banco, MD         
Sub-Investigator: Marine Thomas, MD         
CHRU Lille - Salengro Recruiting
Lille, France, 59000
Contact: Benoît Tavernier, MD         
Principal Investigator: Benoît Tavernier, MD         
Sub-Investigator: Florence Lallemant, MD         
Sub-Investigator: Benjamin Bijok, MD         
Sub-Investigator: Delphine Garrigue, MD         
Sub-Investigator: Morgane Bacus, MD         
Sub-Investigator: Christine Ducam, MD         
Sub-Investigator: Guillaume Strecker, MD         
Sub-Investigator: Elise Blonde, MD         
Sub-Investigator: Nathalie Bruneau, MD         
CHU LILLE - Huriez Recruiting
Lille, France, 59037
Contact: LEBUFFE Gilles, MD         
Principal Investigator: Gilles Lebuffe, MD         
Sub-Investigator: Matthias Garot, MD         
Sub-Investigator: Clément Lemery, MD         
Sub-Investigator: Jérémy Falcone, MD         
Sub-Investigator: Cédric Cirenei, MD         
CHU LYON Recruiting
Lyon, France
Contact: AUBRUN Frédéric, MD         
Principal Investigator: Thomas Rimmele, MD         
Sub-Investigator: Anne Bertin-Maghit (Buisson), MD         
Sub-Investigator: Cécile Faulcon, MD         
Sub-Investigator: Jullien Jérôme Crozon, MD         
Sub-Investigator: Frédérique Jeanne Yvla Bayle, MD         
Sub-Investigator: Arnaud Gregoire, MD         
Sub-Investigator: Catherine Jadaud, MD         
Sub-Investigator: Julien Davidson, MD         
Sub-Investigator: Mary Charlotte Le Goff, MD         
Sub-Investigator: Thomas Geffriaud, MD         
Sub-Investigator: Thomas Uberti, MD         
Sub-Investigator: Yves Bouffard, MD         
Sub-Investigator: Charles-Eric Ber, MD         
Sub-Investigator: Maëva Durand, MD         
Sub-Investigator: Ana Casandra Nicoara, MD         
Sub-Investigator: Alexandre Faure, MD         
Sub-Investigator: Florent Moriceau, MD         
Sub-Investigator: Najia Rahali, MD         
Sub-Investigator: Laetitia Huriaux, MD         
Sub-Investigator: Véronique Leray, MD         
Sub-Investigator: Baptiste Hengy, MD         
Sub-Investigator: Benjamin Delwarde, MD         
Sub-Investigator: Bertrand Devigne, MD         
Sub-Investigator: Nada Nargues, MD         
Sub-Investigator: Martin Bonnassieux, MD         
Sub-Investigator: Stéphen Lazaar, MD         
Sub-Investigator: Anne-Sophie Bellocq, MD         
Sub-Investigator: Jean-François Carabalona, MD         
Sub-Investigator: Claire Delsuc, MD         
Sub-Investigator: François Malavieille, MD         
Sub-Investigator: Violette Zorio, MD         
Lyon Sud - CHU Recruiting
Lyon, France
Contact: Jean Stéphane David, MD         
Principal Investigator: Jean Stéphane David, MD         
Sub-Investigator: Vincent Piriou, MD         
Sub-Investigator: Pierre Yves Petit, MD         
Sub-Investigator: Mathilde Lefevre, MD         
Sub-Investigator: Pascal Incagnoli, MD         
Sub-Investigator: Bruno Baffeleuf, MD         
Sub-Investigator: Camille Bouisse, MD         
Sub-Investigator: Camille Parent, MD         
Sub-Investigator: Emilie Rulliat, MD         
Sub-Investigator: Jérôme Gauthier, MD         
Sub-Investigator: Marie Christine Laplace, MD         
Sub-Investigator: Mélanie Bauducel, MD         
Sub-Investigator: Irène Vallecorsa, MD         
Sub-Investigator: Nicolas Hernandez, MD         
Sub-Investigator: Mélanie Levrard, MD         
Sub-Investigator: Christelle Rouget, MD         
Chu Marseille La Timone Recruiting
Marseille, France, 13385
Contact: BRUDER Nicolas, MD         
Principal Investigator: Nicolas BRUDER, MD         
Sub-Investigator: Camille Vaisse, MD         
Sub-Investigator: Thomas Levy, MD         
Sub-Investigator: Michèle Bertrandy Loubat, MD         
Chu Marseille Nord Recruiting
Marseille, France, 13385
Contact: LEONE Marc, MD         
Principal Investigator: Marc LEONE, MD         
Sub-Investigator: Agnès Vincent, MD         
Sub-Investigator: Béatrice Michel, MD         
Sub-Investigator: Laureen Bernard, MD         
Sub-Investigator: Frédéric Potié, MD         
Sub-Investigator: Gary Duclos, MD         
Sub-Investigator: Marion Poirier, MD         
Sub-Investigator: Nathalie Lesavre, MD         
Sub-Investigator: Alexandre Mignon, MD         
Sub-Investigator: Aurélie Bourgoin, MD         
Sub-Investigator: Jeanne Chatelon, MD         
Sub-Investigator: Marie Courty, MD         
Chu Montpellier Recruiting
Montpellier 5, France, 34295
Contact: Samir JABER, MD         
Principal Investigator: Samir JABER, MD         
Sub-Investigator: Moujib Baccari, MD         
Sub-Investigator: Anna Castagnoli, MD         
Sub-Investigator: Elisabeth Cuchet, MD         
Sub-Investigator: Marie Geniez, MD         
Sub-Investigator: Virginie Marre, MD         
Sub-Investigator: Alice Millot, MD         
Sub-Investigator: Yvan Pouzeratte, MD         
Sub-Investigator: Pierre Trinh-Duc, MD         
Sub-Investigator: Daniel Verzilli, MD         
Sub-Investigator: Gérald Chanques, MD         
Sub-Investigator: Audrey De Jong, MD         
Chu Nancy Recruiting
Nancy, France, 54035
Contact: Claude MEISTELMAN, MD         
Principal Investigator: Claude MEISTELMAN, MD         
Sub-Investigator: Denis Schmartz, MD         
Sub-Investigator: Julien Birckener, MD         
Sub-Investigator: Gaittha Munagamage, MD         
CHU de Nantes Recruiting
Nantes, France
Contact: Karim Asehnoune, MD         
Principal Investigator: Karim Asehnoune, MD         
Sub-Investigator: Antoine Roquilly, MD         
Sub-Investigator: Aurore Desdoits, MD         
Sub-Investigator: Florence Renzo Pousset, MD         
Sub-Investigator: Rémi Montreul, MD         
Sub-Investigator: Martin Liard, MD         
Sub-Investigator: Omar Amrani, MD         
Sub-Investigator: Tanguy Cazaubiel, MD         
Sub-Investigator: Marie Bruckler, MD         
Sub-Investigator: Anne-Marine Plouhinec, MD         
Sub-Investigator: Laurent Da Mata, MD         
Sub-Investigator: Marguerite Le Pendu, MD         
CHU NICE Not yet recruiting
Nice, France
Contact: CARLES Michel, MD         
Principal Investigator: CARLES Michel, MD         
Chu Nimes Recruiting
Nîmes, France
Contact: LEFRANT Jean-Yves, MD         
Principal Investigator: Philippe Cuvillon, MD         
Sub-Investigator: Gautier Buzançais, MD         
Sub-Investigator: Mathieu Briere, MD         
Sub-Investigator: Grégoire Coin, MD         
Sub-Investigator: Cédric Folcher, MD         
Sub-Investigator: Olivier Wira, MD         
Ch Paris Beaujon Recruiting
Paris, France
Contact: Catherine PAUGAM, MD         
Principal Investigator: Catherine PAUGAM, MD         
Sub-Investigator: Mohamed Gloulou, MD         
Sub-Investigator: Isabelle Enriquez, MD         
Sub-Investigator: Camille Hego, MD         
Sub-Investigator: Juliette Kavafyan Lasserre, MD         
Sub-Investigator: Adelina Nicoleta Popescu, MD         
Sub-Investigator: Aymeric Restoux, MD         
Sub-Investigator: Flora Cipriani, MD         
Sub-Investigator: Vlad Suparschi, MD         
Sub-Investigator: Nazim Abdelkrim, MD         
Ch Paris Bichat Recruiting
Paris, France
Contact: Philippe Montravers, MD         
Principal Investigator: Philippe Montravers, MD         
Sub-Investigator: Elie Kantor, MD         
Sub-Investigator: Fabien Lion, MD         
Sub-Investigator: Emmanuel Couderc, MD         
Sub-Investigator: Aurélie Gouel, MD         
Sub-Investigator: Angèle Neouze, MD         
Ch Paris Pitie Salpetriere Recruiting
Paris, France
Contact: Mathieu RAUX, MD         
Principal Investigator: Mathieu Raux, MD         
Sub-Investigator: Denis Lemesle, MD         
Sub-Investigator: Jeff Guezennec, MD         
Sub-Investigator: Emmanuelle Dolla, MD         
Sub-Investigator: Elsa Lidzborski, MD         
Sub-Investigator: Arthur Davy, MD         
Sub-Investigator: Frédéric Le Saché, MD         
Sub-Investigator: Pauline Glasman, MD         
Sub-Investigator: Dimitri Margetis, MD         
Ch Paris Saint Antoine Recruiting
Paris, France
Contact: Thomas Lescot, MD         
Principal Investigator: Thomas Lescot, MD         
Sub-Investigator: Marc Beaussier, MD         
Sub-Investigator: Kailai Xu, MD         
Sub-Investigator: Manar Maarouf, MD         
Sub-Investigator: Nicolas Fallouh, MD         
Sub-Investigator: Camille Godart, MD         
Sub-Investigator: Franck Verdonk, MD         
Sub-Investigator: Emilie Begneu, MD         
Sub-Investigator: Jessica Tran Van Nho, MD         
Sub-Investigator: Fanny Garnier, MD         
Ch Saint Louis-Lariboisiere Recruiting
Paris, France
Contact: Benoît PLAUD, MD         
Principal Investigator: Benoît PLAUD, MD         
Sub-Investigator: François Bart, MD         
Sub-Investigator: Eric Roland, MD         
Sub-Investigator: Marine Coroir, MD         
Sub-Investigator: Alice Blet, MD         
Sub-Investigator: Aristide Ntahe, MD         
Sub-Investigator: Charles Coudriou, MD         
Sub-Investigator: Claire Mayeur, MD         
Chu Poitiers Recruiting
Poitiers, France, 86021
Contact: Matthieu Boisson, MD         
Sub-Investigator: Bertrand DEBAENE, MD         
Principal Investigator: Matthieu Boisson, MD         
Sub-Investigator: Denis Frasca, MD         
Chu Rennes Recruiting
Rennes, France
Contact: Hélène BELOEIL, MD         
Principal Investigator: Hélène BELOEIL, MD         
Sub-Investigator: Gilles Godet, MD         
Sub-Investigator: Grégoire Le Gac, MD         
Sub-Investigator: Maria Lahlou-Casulli, MD         
Sub-Investigator: Adrien Le Dain, MD         
Sub-Investigator: Nicolas Nesseler, MD         
Chu Rouen Not yet recruiting
Rouen, France, 76031
Contact: DUREUIL Bertrand, MD    0232888990      
Principal Investigator: DUREUIL Bertrand, MD         
Sub-Investigator: COMPERE Vincent, MD         
Chu Saint Etienne Recruiting
Saint Etienne, France, 42100
Contact: MOLLIEX Serge, MD         
Principal Investigator: Serge Molliex, MD         
Sub-Investigator: Sylvie Passot, MD         
Sub-Investigator: Pierre Lambert, MD         
Sub-Investigator: Jean-Yves Bien, MD         
Sub-Investigator: Paul Zufferey, MD         
Sub-Investigator: Charline Tourel, MD         
Sub-Investigator: Brigitte Beauchesne, MD         
Sub-Investigator: Fabrizio Sandri, MD         
Sub-Investigator: Jean-Charles Palao, MD         
Sub-Investigator: Zeina Prades, MD         
Sub-Investigator: Bertrand Guillot, MD         
Sub-Investigator: Xavier Pingault, MD         
Sub-Investigator: Julie Galland, MD         
Sub-Investigator: Anne Marie Beraud, MD         
Sub-Investigator: Berrada Berthier, MD         
Sub-Investigator: Nathalie Grand, MD         
Sub-Investigator: Ben Salim Aissaoui, MD         
Sub-Investigator: Julien Lanoiselée, MD         
Sub-Investigator: Sahar Awad, MD         
Sub-Investigator: Magalie Dumas, MD         
Sub-Investigator: Nicolas Surcin-Tsekouras, MD         
Hopital Central Strasbourg Recruiting
Strasbourg, France, 67098
Contact: Michel MERTES, MD         
Principal Investigator: Michel MERTES, MD         
Sub-Investigator: Olivier Collange, MD         
Sub-Investigator: Louis Profumo, MD         
Sub-Investigator: François Levy, MD         
Sub-Investigator: Vianney Kieffer, MD         
Sub-Investigator: Alexander Simon Bernemann, MD         
Sub-Investigator: Juliette Marcantoni, MD         
Sub-Investigator: Matthieu Zappaterra, MD         
Hopital Hautepierre Strasbourg Recruiting
Strasbourg, France, 67098
Contact: Pierre DIEMUNSCH, MD         
Principal Investigator: Pierre DIEMUNSCH, MD         
Sub-Investigator: Laurence Oehlkern, MD         
Sub-Investigator: David Joganah, MD         
Sub-Investigator: Ioana Monica Badu, MD         
Sub-Investigator: Lucas Dreyfuss, MD         
Sub-Investigator: Nadine Gengenwin, MD         
Sub-Investigator: Stefan Skwirba, MD         
Sub-Investigator: Eric Noll, MD         
Chu Toulouse Recruiting
Toulouse 9, France, 31059
Contact: Vincent MINVILLE, MD    0561778233      
Principal Investigator: Vincent MINVILLE, MD         
Sub-Investigator: Fabrice FERRE, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: MOLLIEX Serge, MD CHU SAINT ETIENNE

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02668250     History of Changes
Other Study ID Numbers: 1508190
ANSM ( Other Identifier: 2016-A00667-44 )
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Failure
Lung Diseases
Vascular Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Renal Insufficiency
Alcoholism
Peripheral Vascular Diseases
Peripheral Arterial Disease
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Kidney Diseases
Urologic Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Respiration Disorders
Heart Valve Diseases
Anesthetics