Periinterventional Outcome Study in the Elderly

Study Overview
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Brief Summary
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The POSE study will predict critical stages and outcome in a large sample of all surgical and non-surgical interventional patients ≥80 years of age in Europe.

Detailed Description
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Elderly population (≥80 years) will increase from 5.3% of the total population in 2015 to 9% in 2040. This implies an increasing number and variety of surgical and non-surgical interventional procedures. Little is known about the in-hospital mortality rates in the overall elderly interventional population. Compared with younger interventional patients, the elderly are at greater risk of peri-interventional mortality and morbidity, because of decline in physiological and cognitive reserve, and frequent comorbidities. Previous data are mostly limited to specific populations, like the elderly hip fracture patient. The investigators aim to recruit as many as possible centers throughout Europe, to participate in this study. A total sample size of 7500 patients will provide reasonable and valid results for the study aims. The primary endpoint will be analysed by fitting a COX-Regression model to the data of the post-interventional mortality until day 30.

Official Title
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Periinterventional Outcome Study in the Elderly (POSE): European, Multi-centre, Prospective Observational Cohort Study

Conditions
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Mortality, Complication, Postoperative

Intervention / Treatment
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* Procedure: Surgical or non-surgical intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 80 years Written informed consent according to the national law requirements All consecutive patients undergoing surgical and non-surgical interventions (e.g. radiological, neuroradiological, cardiological, gastroenterological) with anaesthesia care (done by an anaesthetist) within the selected inclusion period of four weeks Elective and emergency procedures In-patient and out-patient procedures Exclusion Criteria: People who are institutionalized by court or administrative order Patients with re-intervention within the 4 week period, who were already enrolled in this study

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elderly patient<br>Elderly patient undergoing surgical and non-surgical intervention with the use of anesthesia provided by an anesthetist | Procedure: Surgical or non-surgical intervention<br>* Each kind of surgical or non-surgical intervention with anesthesia applied by an anesthetist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-interventional (surgical and non-surgical interventional) all-cause mortality rate on day 30 | Number of patients with death from any cause | From intervention until day 30. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital outcome according to the ACS National Surgical Quality Improvement Program® (ACS NSQIP®) | Number of patients with e.g. pneumonia, cardiovascular complication, surgical site infection, urinary tract infection, venous thromboembolism, acute or progressive renal failure and re-surgery | From intervention until day 30. | 
| Analysis of the new-onset of serious cardiac complications | Number of patients with serious cardiac complication Cardiac complication is defined according to the American Heart Association | From intervention up to 30-days after intervention | 
| Analysis of the new-onset of serious pulmonary complications | Number of patients with Pneumonia: Clinical or radiological diagnosis. or Pulmonary embolism: Radiological diagnosis. Signs of pneumonia or pulmonary embolism in the autopsy | From intervention up to 30-days after intervention | 
| Analysis of the new-onset of acute stroke | Number of patients with new-onset of acute stroke, defined as a new focal or generalised neurological deficit of >24h duration in motor, sensory, or coordination functions with compatible brain imaging and confirmed by a neurologist. Transient ischemic attack is not considered as acute stroke. Signs of stroke in the autopsy. | From intervention up to 30-days after intervention | 
| Analysis of the new-onset of acute kidney injury | Number of patients with new-onset of acute kidney injury, defined according to the AKIN classification as AKI stage ≥2. This means increase of creatinine >2-3x from baseline within the hospital stay. Or urine output less than 0.5 ml kg-1 per hour for more than 12 hours. Or signs of acute kidney injury in the autopsy. | From intervention up to 30-days after intervention | 
| Unplanned intensive care unit admission | Number of patients | From intervention until hospital discharge or maximum 30-days after intervention | 
| Unplanned intubation after intervention | Number of patients | From intervention until hospital discharge or maximum 30-days after intervention | 
| Hospital discharge destination | Number of patients, who are not discharged, discharged home, discharged to rehabilitation, discharged to other hospital, discharged to a nursing home, diseased in hospital or discharged to another destination, respectively. | From intervention until hospital discharge or maximum 30-days after intervention | 
| Perioperative admission to a unit with a geriatric care model | Number of patients, which are post-interventionally admitted to e.g. geriatric units, geriatric co-management models, geriatric liaison services | From intervention until hospital discharge or maximum 30-days after intervention | 
| Patient's functional status of independency | Scale assessed by interview of the patient according to the NSQIP (Independent, partially dependent, totally dependent). | On day 30 after intervention | 
| Brief screen for cognitive impairment | Number of correct recall of three words (Brief Screen for Cognitive Impairment test) | On day 30 after intervention | 
| Comparing the postoperative in-hospital and 30-day outcome with preoperatively via NSQIP risk calculator and POSPOM predicted outcome for surgeries | Comparing the number of via preoperative NSQIP risk calculator and POSPOM predicted outcomes with the number of postoperative outcomes of the patient | On day 30 after intervention | 
| Number of used intra-interventional monitoring for elderly patients in the clinical routine | Number of patients, where a specific monitoring device was intra-interventionally used | Intra-interventional | 
| Number of patients with premedication | Number of patients with premedication given before intervention. | Intra-interventional | 
| Type of anesthesia technique | Number of patients with a specific type of anesthesia technique (e.g. spinal, general etc) | Intra-interventional | 
| Type of the main anesthetic | Number of patients with a specific type of anesthesia drugs (e.g. desflurane, isoflurane etc.) | Intra-interventional | 
| Type of the main intra-interventional opioid | Number of patients with a specific type of opioid for anesthesia (e.g. fentanyl etc.) | Intra-interventional | 
| Anesthesia duration | Begin to end of anesthesia for intervention | Intra-interventional | 
| Amount of intra-interventionally transfused blood and blood products | e.g. transfusion of packed red blood cells, fresh frozen plasmas and platelets | Intra-interventional | 
| Number of extubated patients | At the end of intervention | Intra-interventional | 
| Kind of intervention | Surgical procedure category, severity, urgency, wound class | Intra-interventional | 
| Use of WHO safe surgery checklist | Number of patients , where the WHO safe surgery checklist was used | Intra-interventional | 
| Kind of referring facility | Number of patients referred from home,other hospital, rehabilitation, nursing home or other referring facility, respectively. | Pre-interventional at baseline visit | 
| Amount of pre-interventional comorbidities | Number of comorbidities | pre-interventional at baseline visit | 
| Albumin and hematocrit level before intervention | Optional assessment, only if done in the clinical routine | pre-interventional at baseline visit | 
| Number of falls in the last 6 months | Number of falls per patient | pre-interventional at baseline visit | 
| Mini-Cog (for the cognitive status) | Performance of the mini-cog test and analysis of the maximum points in this test | pre-interventional at baseline visit | 
| Pre-interventional timed Up & Go test | Seconds to perform the up and go test will be measured | pre-interventional at baseline visit | 
| Comparison of the patients' outcomes across Europe | Comparing the number of adverse outcomes between the hospitals and countries | 30 days after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly patients, Mortality, morbidity, post-intervention