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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02668250
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : August 26, 2021
Sponsor:
Collaborator:
Ministry of Health, France
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)
Actual Enrollment : 2495 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
Actual Primary Completion Date : February 5, 2020
Actual Study Completion Date : March 16, 2021

Resource links provided by the National Library of Medicine


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 composite of mortality or major postoperative morbidity. [ Time Frame: Day 30 ]
    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.



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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


Locations
Show Show 29 study locations
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
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    
Other Study ID Numbers: 1508190
ANSM ( Other Identifier: 2016-A00667-44 )
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
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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Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Renal Insufficiency
Arrhythmias, Cardiac
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Alcoholism
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Mental Disorders
Pathologic Processes
Lung Diseases, Obstructive
Kidney Diseases
Urologic Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Respiration Disorders