Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality
OPTI-AGED
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
2 other identifiers
interventional
2,495
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2016
CompletedFirst Posted
Study publicly available on registry
January 29, 2016
CompletedStudy Start
First participant enrolled
February 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2021
CompletedAugust 26, 2021
August 1, 2021
3 years
January 22, 2016
August 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Experimental group : OPTI-AGED
EXPERIMENTALThe OPTI-AGED group will receive a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia.
Control Group :
ACTIVE COMPARATORThe control group will not benefit from the OPTI-AGED intervention but patients will receive the usual care.
Interventions
OPTI-AGED is composed of a multi-parametric optimization strategy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
CHU Amiens - Picardie
Amiens, France
CHU CAEN
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
Related Publications (1)
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.
PMID: 29921685DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MOLLIEX Serge, MD
CHU SAINT-ETIENNE
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2016
First Posted
January 29, 2016
Study Start
February 3, 2017
Primary Completion
February 5, 2020
Study Completion
March 16, 2021
Last Updated
August 26, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share