Periinterventional Outcome Study in the Elderly

Mark Coburn9,500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

9,500

Conditions

Mortality Complication, Postoperative

Interventions

Surgical or non-surgical interventionPROCEDURE

Each kind of surgical or non-surgical intervention with anesthesia applied by an anesthetist

Eligibility

Sex: ALLMin age: 80 Years

Medical Language ↔ Plain English

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

Locations (177)

Outcomes

Primary Outcomes

Peri-interventional (surgical and non-surgical interventional) all-cause mortality rate on day 30

Number of patients with death from any cause

Time frame: From intervention until day 30.

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: From intervention up to 30-days after intervention

Analysis of the new-onset of acute kidney injury

Data from ClinicalTrials.gov

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University Hospital Salzburg

Salzburg, Austria

ZNA Middelheim

Antwerp, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

Ghent University Hospital

Ghent, Belgium

AZ Groeninge

Kortrijk, Belgium

University Hospital Leuven

Leuven, Belgium

AZ Turnhout

Turnhout, Belgium

Aarhus Universityhospital

Aarhus, Denmark

Rigshospitalet, Neuroscience Centre

Copenhagen, Denmark

...and 167 more locations

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.

Time frame: From intervention up to 30-days after intervention

Unplanned intensive care unit admission

Number of patients

Time frame: From intervention until hospital discharge or maximum 30-days after intervention

Unplanned intubation after intervention

Number of patients

Time frame: 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.

Time frame: 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

Time frame: 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).

Time frame: On day 30 after intervention

Brief screen for cognitive impairment

Number of correct recall of three words (Brief Screen for Cognitive Impairment test)

Time frame: 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

Time frame: 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