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

Stroke Clinical Trial

— OPTI-AGED  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668250
• Other study ID #: 1508190
• Secondary ID: ANSM
• Status: Completed
• Phase: N/A
• Start date: February 3, 2017
• Est. completion date: March 16, 2021

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2495
• Est. completion date: March 16, 2021
• Est. primary completion date: February 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism
• Arrhythmias, Cardiac
• Cancer
• Coronary; Ischemic
• Dementia
• Diabetes
• Heart Failure
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Valve Insufficiency
• Renal Insufficiency
• Respiratory Insufficiency
• Stroke
• Vascular Diseases

Intervention

Procedure:
• OPTI-AGED
OPTI-AGED is composed of a multi-parametric optimization strategy.
• Usual Care
Patients receive the usual care.

Locations

Country	Name	City	State
France	CHU Amiens - Picardie	Amiens
France	CHU CAEN	Caen
France	Chu Clermont-Ferrand	Clermont-Ferrand
France	Médipôle Lyon - Villeurbanne	Décines-Charpieu
France	Chu Dijon	Dijon
France	Chu Grenoble	Grenoble 9
France	CHRU Lille - Salengro	Lille
France	CHU LILLE - Huriez	Lille
France	CHU LYON	Lyon
France	Lyon Sud - CHU	Lyon
France	Chu Marseille La Timone	Marseille
France	Chu Marseille Nord	Marseille
France	Chu Montpellier	Montpellier 5
France	Chu Nancy	Nancy
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
France	Chu Rennes	Rennes
France	Chu Rouen	Rouen
France	Chu Saint Etienne	Saint Etienne
France	Hopital Central Strasbourg	Strasbourg
France	Hopital Hautepierre Strasbourg	Strasbourg
France	Chu Toulouse	Toulouse 9

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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