An interventional study of OPTI-AGED and Usual Care in Coronary; Ischemic, Arrhythmias, Cardiac and Heart Failure, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 29 sites in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2021-08-26.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Supportive care
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 2,495 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
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Exclusion Criteria:
The OPTI-AGED group will receive a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia.
Procedure: OPTI-AGED
The control group will not benefit from the OPTI-AGED intervention but patients will receive the usual care.
Procedure: Usual Care
OPTI-AGED is composed of a multi-parametric optimization strategy.
Patients receive the usual care.
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.
Time frame: Day 30
Plan to share: No
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
Centre Hospitalier Universitaire de Saint Etienne