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

Mark Coburn177 sites in 5 countries9,500 target enrollmentOctober 1, 2017

ConditionsMortality Complication, Postoperative

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mortality
Sponsor: Mark Coburn
Enrollment: 9500
Locations: 177
Primary Endpoint: Peri-interventional (surgical and non-surgical interventional) all-cause mortality rate on day 30
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2017

End Date

January 30, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Mark Coburn

Responsible Party

Sponsor Investigator

Principal Investigator

Mark Coburn

Prof. Dr. med. Mark Coburn

RWTH Aachen University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: From intervention until day 30.

Number of patients with death from any cause

Secondary Outcomes

Analysis of the new-onset of serious cardiac complications(From intervention up to 30-days after intervention)
Analysis of the new-onset of serious pulmonary complications(From intervention up to 30-days after intervention)
Analysis of the new-onset of acute stroke(From intervention up to 30-days after intervention)
In-hospital outcome according to the ACS National Surgical Quality Improvement Program® (ACS NSQIP®)(From intervention until day 30.)
Analysis of the new-onset of acute kidney injury(From intervention up to 30-days after intervention)
Unplanned intensive care unit admission(From intervention until hospital discharge or maximum 30-days after intervention)
Hospital discharge destination(From intervention until hospital discharge or maximum 30-days after intervention)
Unplanned intubation after intervention(From intervention until hospital discharge or maximum 30-days after intervention)
Brief screen for cognitive impairment(On day 30 after intervention)
Type of the main anesthetic(Intra-interventional)
Type of the main intra-interventional opioid(Intra-interventional)
Perioperative admission to a unit with a geriatric care model(From intervention until hospital discharge or maximum 30-days after intervention)
Comparing the postoperative in-hospital and 30-day outcome with preoperatively via NSQIP risk calculator and POSPOM predicted outcome for surgeries(On day 30 after intervention)
Type of anesthesia technique(Intra-interventional)
Anesthesia duration(Intra-interventional)
Kind of referring facility(Pre-interventional at baseline visit)
Number of extubated patients(Intra-interventional)
Kind of intervention(Intra-interventional)
Use of WHO safe surgery checklist(Intra-interventional)
Comparison of the patients' outcomes across Europe(30 days after intervention)
Amount of pre-interventional comorbidities(pre-interventional at baseline visit)
Albumin and hematocrit level before intervention(pre-interventional at baseline visit)
Number of falls in the last 6 months(pre-interventional at baseline visit)
Mini-Cog (for the cognitive status)(pre-interventional at baseline visit)
Pre-interventional timed "Up & Go" test(pre-interventional at baseline visit)
Patient's functional status of independency(On day 30 after intervention)
Number of used intra-interventional monitoring for elderly patients in the clinical routine(Intra-interventional)
Number of patients with premedication(Intra-interventional)
Amount of intra-interventionally transfused blood and blood products(Intra-interventional)