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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2016-A00667-44 |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group : OPTI-AGED | Experimental | The OPTI-AGED group will receive a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia. |
|
| Control Group : | Active Comparator | The control group will not benefit from the OPTI-AGED intervention but patients will receive the usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPTI-AGED | Procedure | OPTI-AGED is composed of a multi-parametric optimization strategy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of a composite of mortality or major postoperative morbidity. | One or more of major postoperative complications : acute kidney injury (defined by Kidney disease : improving Global Outcomes (KDIGO) stage 1 or higher), acute myocardial infarction, heart failure, stroke, development of sepsisand septic shock, acute respiratory failure requiring non-invasive 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. | Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MOLLIEX Serge, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens - Picardie | Amiens | France | ||||
| CHU CAEN |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29921685 | Derived | Molliex S, Passot S, Futier E, Bonnefoi M, Rancon F, Lemanach Y, Pereira B. Stepped wedge cluster randomised controlled trial to assess the effectiveness of an optimisation strategy for general anaesthesia on postoperative morbidity and mortality in elderly patients (the OPTI-AGED study): a study protocol. BMJ Open. 2018 Jun 19;8(6):e021053. doi: 10.1136/bmjopen-2017-021053. |
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| Usual Care | Procedure | Patients receive the usual care. |
|
| Caen |
| France |
| Chu Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| Médipôle Lyon - Villeurbanne | Décines-Charpieu | France |
| Chu Dijon | Dijon | 21079 | France |
| Chu Grenoble | Grenoble | 38043 | France |
| CHRU Lille - Salengro | Lille | 59000 | France |
| CHU LILLE - Huriez | Lille | 59037 | France |
| CHU LYON | Lyon | France |
| Lyon Sud - CHU | Lyon | France |
| Chu Marseille La Timone | Marseille | 13385 | France |
| Chu Marseille Nord | Marseille | 13385 | France |
| Chu Montpellier | Montpellier | 34295 | France |
| Chu Nancy | Nancy | 54035 | France |
| CHU de Nantes | Nantes | France |
| CHU NICE | Nice | France |
| Chu Nimes | Nîmes | France |
| Ch Paris Beaujon | Paris | France |
| Ch Paris Bichat | Paris | France |
| Ch Paris Pitie Salpetriere | Paris | France |
| Ch Paris Saint Antoine | Paris | France |
| Ch Saint Louis-Lariboisiere | Paris | France |
| Chu Poitiers | Poitiers | 86021 | France |
| Chu Rennes | Rennes | France |
| Chu Rouen | Rouen | 76031 | France |
| Chu Saint Etienne | Saint-Etienne | 42100 | France |
| Hopital Central Strasbourg | Strasbourg | 67098 | France |
| Hopital Hautepierre Strasbourg | Strasbourg | 67098 | France |
| Chu Toulouse | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D007511 | Ischemia |
| D001145 | Arrhythmias, Cardiac |
| D006333 | Heart Failure |
| D016491 | Peripheral Vascular Diseases |
| D003704 | Dementia |
| D020521 | Stroke |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012131 | Respiratory Insufficiency |
| D000437 | Alcoholism |
| D009369 | Neoplasms |
| D003920 | Diabetes Mellitus |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D012120 | Respiration Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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