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

Recruiting

Phase N/A Results N/A

Update History

25 Aug '17
The description was updated.
New
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.
Old
The population is expanding and aging. With the increasing aging population demographics and life expectancies, the number of very elderly patients (age ≥ 80) undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group. In 2010, patients aged 80 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.
The minimum age criteria for eligibility was updated to "75 Years."
The eligibility criteria were updated.
New
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
Old
Inclusion Criteria: - All adult patients aged 80 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
23 Aug '17
A location was updated in Marseille.
New
The overall status was updated to "Recruiting" at Chu Marseille La Timone.
A location was updated in Marseille.
New
The overall status was updated to "Recruiting" at Chu Marseille Nord.
A location was updated in Montpellier 5.
New
The overall status was updated to "Recruiting" at Chu Montpellier.
A location was updated in Toulouse 9.
New
The overall status was updated to "Recruiting" at Chu Toulouse.
8 Jul '17
The Summary of Purpose was updated.
New
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.
Old
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 description was updated.
New
The population is expanding and aging. With the increasing aging population demographics and life expectancies, the number of very elderly patients (age ≥ 80) undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group. In 2010, patients aged 80 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.
Old
The population is expanding and aging. With the increasing aging population demographics and life expectancies, the number of very elderly patients (age ≥ 80) undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group. In 2010, patients aged 80 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.
The eligibility criteria were updated.
New
Inclusion Criteria: - All adult patients aged 80 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
Old
Inclusion Criteria: - All adult patients aged 80 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
3 May '17
The gender criteria for eligibility was updated to "All."
A location was updated in Caen.
New
The overall status was updated to "Recruiting" at CHU CAEN.
A location was updated in Clermont-Ferrand.
New
The overall status was updated to "Recruiting" at CHU Clermont-Ferrand.
A location was updated in Grenoble 9.
New
The overall status was updated to "Recruiting" at Chu Grenoble.
A location was updated in Lille.
New
The overall status was updated to "Recruiting" at CHU Lille.
A location was updated in Lyon.
New
The overall status was updated to "Recruiting" at CHU Lyon.
A location was updated in Nancy.
New
The overall status was updated to "Recruiting" at Chu Nancy.
A location was updated in Nîmes.
New
The overall status was updated to "Recruiting" at Chu Nimes.
A location was updated in Paris.
New
The overall status was updated to "Recruiting" at Ch Paris Beaujon.
A location was updated in Paris.
New
The overall status was updated to "Recruiting" at Ch Paris Bichat.
A location was updated in Paris.
New
The overall status was updated to "Recruiting" at Ch Paris Pitie Salpetriere.
A location was updated in Paris.
New
The overall status was updated to "Recruiting" at Ch Paris Saint Antoine.
A location was updated in Paris.
New
The overall status was updated to "Recruiting" at Ch Saint Louis-Lariboisiere.
A location was updated in Poitiers.
New
The overall status was updated to "Recruiting" at CHU Poitiers.
A location was updated in Rennes.
New
The overall status was updated to "Recruiting" at CHU Rennes.
A location was updated in Saint Etienne.
New
The overall status was updated to "Recruiting" at Chu Saint Etienne.
A location was updated in Strasbourg.
New
The overall status was updated to "Recruiting" at Hopital Central Strasbourg.
A location was updated in Strasbourg.
New
The overall status was updated to "Recruiting" at Hopital Hautepierre Strasbourg.