Periinterventional Outcome Study in the Elderly

Completed

• Conditions: Mortality; Complication, Postoperative

• Registration Number: NCT03152734
• Lead Sponsor: Mark Coburn

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.

Study Timeline

• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-15
• Study Start: 2017-10-01
• Primary Completion: 2019-01-30
• Study Completion: 2019-01-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-19
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peri-interventional (surgical and non-surgical interventional) all-cause mortality rate on day 30	From intervention until day 30.	Number of patients with death from any cause

Secondary Outcome Measures

Name	Time	Method
Analysis of the new-onset of serious cardiac complications	From intervention up to 30-days after intervention	Number of patients with serious cardiac complication; Cardiac complication is defined according to the American Heart Association
Analysis of the new-onset of serious pulmonary complications	From intervention up to 30-days after intervention	Number of patients with; * Pneumonia: Clinical or radiological diagnosis. or; * Pulmonary embolism: Radiological diagnosis. Signs of pneumonia or pulmonary embolism in the autopsy
Analysis of the new-onset of acute stroke	From intervention up to 30-days after intervention	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.
In-hospital outcome according to the ACS National Surgical Quality Improvement Program® (ACS NSQIP®)	From intervention until day 30.	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
Analysis of the new-onset of acute kidney injury	From intervention up to 30-days after intervention	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.
Unplanned intensive care unit admission	From intervention until hospital discharge or maximum 30-days after intervention	Number of patients
Hospital discharge destination	From intervention until hospital discharge or maximum 30-days after intervention	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.
Unplanned intubation after intervention	From intervention until hospital discharge or maximum 30-days after intervention	Number of patients
Brief screen for cognitive impairment	On day 30 after intervention	Number of correct recall of three words (Brief Screen for Cognitive Impairment test)
Type of the main anesthetic	Intra-interventional	Number of patients with a specific type of anesthesia drugs (e.g. desflurane, isoflurane etc.)
Type of the main intra-interventional opioid	Intra-interventional	Number of patients with a specific type of opioid for anesthesia (e.g. fentanyl etc.)
Perioperative admission to a unit with a geriatric care model	From intervention until hospital discharge or maximum 30-days after intervention	Number of patients, which are post-interventionally admitted to e.g. geriatric units, geriatric co-management models, geriatric liaison services
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	Comparing the number of via preoperative NSQIP risk calculator and POSPOM predicted outcomes with the number of postoperative outcomes of the patient
Type of anesthesia technique	Intra-interventional	Number of patients with a specific type of anesthesia technique (e.g. spinal, general etc)
Anesthesia duration	Intra-interventional	Begin to end of anesthesia for intervention
Number of extubated patients	Intra-interventional	At the end of intervention
Kind of referring facility	Pre-interventional at baseline visit	Number of patients referred from home,other hospital, rehabilitation, nursing home or other referring facility, respectively.
Kind of intervention	Intra-interventional	Surgical procedure category, severity, urgency, wound class
Use of WHO safe surgery checklist	Intra-interventional	Number of patients , where the WHO safe surgery checklist was used
Comparison of the patients' outcomes across Europe	30 days after intervention	Comparing the number of adverse outcomes between the hospitals and countries
Amount of pre-interventional comorbidities	pre-interventional at baseline visit	Number of comorbidities
Number of falls in the last 6 months	pre-interventional at baseline visit	Number of falls per patient
Mini-Cog (for the cognitive status)	pre-interventional at baseline visit	Performance of the mini-cog test and analysis of the maximum points in this test
Pre-interventional timed "Up & Go" test	pre-interventional at baseline visit	Seconds to perform the up and go test will be measured
Patient's functional status of independency	On day 30 after intervention	Scale assessed by interview of the patient according to the NSQIP (Independent, partially dependent, totally dependent).
Number of used intra-interventional monitoring for elderly patients in the clinical routine	Intra-interventional	Number of patients, where a specific monitoring device was intra-interventionally used
Number of patients with premedication	Intra-interventional	Number of patients with premedication given before intervention.
Amount of intra-interventionally transfused blood and blood products	Intra-interventional	e.g. transfusion of packed red blood cells, fresh frozen plasmas and platelets
Albumin and hematocrit level before intervention	pre-interventional at baseline visit	Optional assessment, only if done in the clinical routine

Trial Locations

Locations (177)

University Hospital Salzburg; 🇦🇹 Salzburg, Austria

ZNA Middelheim; 🇧🇪 Antwerpen, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

Ghent University Hospital; 🇧🇪 Gent, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, Belgium

University Hospital Leuven; 🇧🇪 Leuven, Belgium

AZ Turnhout; 🇧🇪 Turnhout, Belgium

Aarhus Universityhospital; 🇩🇰 Aarhus, Denmark

Rigshospitalet, Neuroscience Centre; 🇩🇰 Copenhagen, Denmark

Scroll for more (167 remaining)