Periinterventional Outcome Study in the Elderly
- Conditions
- MortalityComplication, Postoperative
- Interventions
- Procedure: Surgical or non-surgical intervention
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9500
- 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
- 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
- Arm && Interventions
Group Intervention Description Elderly patient Surgical or non-surgical intervention Elderly patient undergoing surgical and non-surgical intervention with the use of anesthesia provided by an anesthetist
- 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 Albumin and hematocrit level before intervention pre-interventional at baseline visit Optional assessment, only if done in the clinical routine
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 AssociationAnalysis 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 autopsyAnalysis 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
Amount of intra-interventionally transfused blood and blood products Intra-interventional e.g. transfusion of packed red blood cells, fresh frozen plasmas and platelets
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.
Trial Locations
- Locations (177)
University Hospital Salzburg
🇦🇹Salzburg, Austria
ZNA Middelheim
🇧🇪Antwerpen, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
University Hospital Leuven
🇧🇪Leuven, Belgium
CHU Angers
🇫🇷Angers, France
Centre hospitalier Pierre Oudot
🇫🇷Bourgoin-Jallieu, France
Huriez Hospital, University Hospital of Lille
🇫🇷Lille, France
Croix Rousse Hospital
🇫🇷Lyon, France
Hôpital Lyon Sud
🇫🇷Lyon, France
AP-HP, Hopital Saint-Louis
🇫🇷Paris, France
CHU Hôpital Nord
🇫🇷Saint-Étienne, France
Hopital de la Pitié-Salpe tri ere
🇫🇷Paris, France
Polyclinique de l'atlantique
🇫🇷Saint-Herblain, France
Centre Hospitalier de Bigorre
🇫🇷Tarbes, France
Clinique Trenel
🇫🇷St Coulomb, France
Hopital Foch
🇫🇷Suresnes, France
Groupe Hospitalier Selestat-Obernai
🇫🇷Sélestat, France
Gustave Roussy Cancer Center
🇫🇷Villejuif, France
Health centre "Medina"
🇬🇪Batumi, Georgia
5th General Hospital "Open Heart"
🇬🇪Tbilisi, Georgia
Acad. N. Kipshidze Central University Clinic
🇬🇪Tbilisi, Georgia
New Hospital
🇬🇪Tbilisi, Georgia
Oftalmij
🇬🇪Tbilisi, Georgia
St. Josef- Hospital
🇩🇪Bochum, Germany
University Hospital Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
University Hospital Frankfurt
🇩🇪Frankfurt, Germany
Hannover Medical School
🇩🇪Hannover, Germany
Marien Hospital Herne, UK der Ruhr-Universität Bochum
🇩🇪Herne, Germany
Universitaetsklinikum Marburg
🇩🇪Marburg, Germany
Klinikum der Ludwigs-Maximilians-Universität München (LMU)
🇩🇪Muenchen, Germany
Klinikum rechts der Isar der TU München
🇩🇪Muenchen, Germany
University Hospital Münster
🇩🇪Münster, Germany
Alexandra Hospital
🇬🇷Athens, Greece
University Hospital Tübingen
🇩🇪Tuebingen, Germany
Evangelismos General Hospital
🇬🇷Athens, Greece
General Hospital of Kavala
🇬🇷Kavála, Greece
University Hospital of Larissa
🇬🇷Larissa, Greece
University Hospital of Patras
🇬🇷Patra, Greece
AHEPA University Hospital
🇬🇷Thessaloníki, Greece
General Hospital Papanikolaou
🇬🇷Thessaloníki, Greece
George Papanikolaou
🇬🇷Thessaloníki, Greece
Medical School, Aristotle University of Thessaloniki
🇬🇷Thessaloníki, Greece
Theagenio Cancer Hospital
🇬🇷Thessaloníki, Greece
General Hospital of Volos "Achillopouleio"
🇬🇷Volos, Greece
General Hospital of Veroia
🇬🇷Véroia, Greece
St Vincents University Hospital
🇮🇪Dublin, Ireland
Tallaght Hospital
🇮🇪Dublin, Ireland
Sheba Academic Medical Center
🇮🇱Ramat Gan, Israel
Maasstad Ziekenhuis
🇳🇱Rotterdam, Netherlands
Jagiellonian University Medical College
🇵🇱Kraków, Poland
Centro Hospitalar e Universitario de Coimbra
🇵🇹Coimbra, Portugal
University Emergency Central Military Hospital
🇷🇴Bucharest, Romania
Centro Hospitalar Lisboa Norte - Hospital Santa Maria
🇵🇹Lisboa, Portugal
Fundeni Clinical Institute
🇷🇴Bucharest, Romania
Emergency County Hospital Cluj
🇷🇴Cluj-Napoca, Romania
GBUZ Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
🇷🇺Chelyabinsk, Russian Federation
P.A. Herzen Moscow Cancer Research Institute
🇷🇺Moscow, Russian Federation
CHC Bezaniska Kosa
🇷🇸Belgrade, Serbia
Clinic for orthopedics surgery and traumatology Clinical center of Serbia
🇷🇸Belgrade, Serbia
Clinical Centre of Serbia
🇷🇸Belgrade, Serbia
Urology Hospital, Clinical center of Serbia
🇷🇸Belgrade, Serbia
General Hospital Sremska Mitrovica
🇷🇸Sremska Mitrovica, Serbia
Emergency Center, Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Clinical Center Nis
🇷🇸Niš, Serbia
CSI Hospital General de l'Hospitalet
🇪🇸Barcelona, Spain
Consorci Sanitari Integral
🇪🇸Barcelona, Spain
Hospital Universitario Fundacion Alcorcon
🇪🇸Alcorcón, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital of Leon
🇪🇸León, Spain
Hospital Universitari Sagrat Cor
🇪🇸Barcelona, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
🇪🇸Las Palmas De Gran Canaria, Spain
Universitary General Hospital of Ciudad Real
🇪🇸Ciudad Real, Spain
San Pedro Hospital
🇪🇸Logroño, Spain
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain
Hospital General Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario Araba
🇪🇸Vitoria, Spain
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital de Sant Joan Despí Moises Broggi - Consorci Sanitari Integral
🇪🇸Sant Joan Despí, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Hospital Clinico Universitario
🇪🇸Valencia, Spain
University Hospital Basel
🇨🇭Basel, Switzerland
Kantonsspital Baselland Liestal
🇨🇭Liestal, Switzerland
Hirslanden Clinic St. Anna Lucern
🇨🇭Lucerne, Switzerland
Spital Limmattal
🇨🇭Schlieren, Switzerland
Bürgerspital Solothurn
🇨🇭Solothurn, Switzerland
Ankara University Faculty of Medicine-Ibni Sina Hospital
🇹🇷Ankara, Turkey
Ankara University Cebeci Hospital
🇹🇷Ankara, Turkey
Ufuk University Dr. Ridvan Ege Hospital
🇹🇷Ankara, Turkey
University of Health Sciences Diskapi Yildirim Beyazit Education and Training Hospital
🇹🇷Ankara, Turkey
Balikesir Atatürk City Hospital
🇹🇷Balıkesir, Turkey
Kocaeli Derince Training and Research Hospital
🇹🇷Derince, Turkey
TR Ministry of Health Erzurum Palandoken State Hospital
🇹🇷Erzurum, Turkey
Baltalimani Metin Sabanci Bone and Joint Diseases Education and Research Hospital
🇹🇷Istanbul, Turkey
Istanbul University, Istanbul Faculty of Medicine
🇹🇷Istanbul, Turkey
Marmara University Pendik Training and Research Hospital
🇹🇷Istanbul, Turkey
Dokuz Eylul University Faculty of Medicine
🇹🇷İzmir, Turkey
Saglik Bilimleri University Tepecik Education and Research Hospital
🇹🇷İzmir, Turkey
Konya Education and Research Hospital
🇹🇷Konya, Turkey
RTE university school of medicine
🇹🇷Rize, Turkey
Sakarya University School od Medicine
🇹🇷Sakarya, Turkey
Republic of Turkey Ministry of Health Tunceli State Hospital
🇹🇷Tunceli, Turkey
Zaporizhzhia State Medical University
🇺🇦Zaporizhzhya, Ukraine
CH Martigues
🇫🇷Martigues, France
Clinique Mutualiste Saint Etienne
🇫🇷Saint-Étienne, France
Medical Corporation Evex - Zugdidi Referral Hospital
🇬🇪Zugdidi, Georgia
University Hospital Knappschaftskrankenhaus Bochum
🇩🇪Bochum, Germany
Heinrich-Heine University Duesseldorf
🇩🇪Duesseldorf, Germany
Universitätsklinikum Schleswig-Holstein Campus Luebeck
🇩🇪Luebeck, Germany
General Hospital of Athens "G. Gennimatas"
🇬🇷Athens, Greece
Attikon University Hospital
🇬🇷Chaïdári, Greece
Galilee Medical Center
🇮🇱Nahariya, Israel
University Clinic for Gyn & Ob / Clinical Center Mother Teresa
🇲🇰Skopje, North Macedonia
Aarhus Universityhospital
🇩🇰Aarhus, Denmark
Rigshospitalet, Neuroscience Centre
🇩🇰Copenhagen, Denmark
Rigshospitalet
🇩🇰Copenhagen, Denmark
Herlev Hospital
🇩🇰Herlev, Denmark
Nordsjællands Hospital
🇩🇰Hillerød, Denmark
Hospital Unit Horsens
🇩🇰Horsens, Denmark
Hospitaln Lillebælt
🇩🇰Vejle, Denmark
Komotini General Hospital
🇬🇷Komotiní, Greece
Ghent University Hospital
🇧🇪Gent, Belgium
AZ Turnhout
🇧🇪Turnhout, Belgium
Hopital d'Instruction des Armées Percy
🇫🇷Clamart, France
Mediclubgeorgia
🇬🇪Tbilisi, Georgia
Jena University Hospital
🇩🇪Jena, Germany
University Hospital of Wuerzburg
🇩🇪Würzburg, Germany
University Hospital of Ioannina
🇬🇷Ioánnina, Greece
Hopital Saint Antoine
🇫🇷Paris, France
AZ Groeninge
🇧🇪Kortrijk, Belgium
HIA Clermont Tonnerre
🇫🇷Brest, France
Centre Hospitalier Universitaire de Nantes
🇫🇷Nantes, France
Hopital Prive Claude Galien
🇫🇷Quincy-sous-Sénart, France
St. Franziskus-Hospital Münster
🇩🇪Münster, Germany
Democritus University of Thrace
🇬🇷Alexandroupolis, Greece
Hippokrateion General Hospital
🇬🇷Thessaloníki, Greece
Rabin Medical Center Beilinson Hospital
🇮🇱Petah tikva, Israel
Albert Schweitzer Hospital
🇳🇱Dordrecht, Netherlands
Hopital Edouard Herriot
🇫🇷Lyon, France
Neurologic Hospital-Hospices Civils de Lyon
🇫🇷Lyon, France
CHU Toulouse
🇫🇷Toulouse, France
Centre Hospitalier Fleyriat
🇫🇷Bourg-en-Bresse, France
AP-HM Hôpital Nord
🇫🇷Marseille, France
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers, France
Department of Anesthesiology, University Hospital Aachen
🇩🇪Aachen, NRW, Germany
Johannes Wesling Klinikum Minden
🇩🇪Minden, Germany
Tzaneio General Hospital of Pireaus
🇬🇷Piraeus, Greece
Cork University Hospital Group
🇮🇪Cork, Ireland
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands
Centro Hospitalar Tamega e Sousa
🇵🇹Penafiel, Portugal
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
🇹🇷Istanbul, Turkey
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium
CHU Amiens Picardie
🇫🇷Amiens, France
CH Le Mans
🇫🇷Le Mans, France
Clinique Saint Jean
🇫🇷Montpellier, France
CHU Nantes
🇫🇷Nantes, France
University Hospital of Reims
🇫🇷Reims, France
EVEX Traumatology Hospital
🇬🇪Tbilisi, Georgia
Medical Corporation Evex, Tbilisi Referral Hospital
🇬🇪Tbilisi, Georgia
University of Bonn
🇩🇪Bonn, Germany
Klinikum Oldenburg AÖR
🇩🇪Oldenburg, Germany
Kliniverbund St. Antonius und St. Josef GmbH
🇩🇪Wuppertal, Germany
Onassis Cardiac Surgery Center
🇬🇷Athens, Greece
Clinique de la Sauvegarde
🇫🇷Lyon, France
Cochin University Hospital
🇫🇷Paris, France
Federal State Autonomous Institution N.N. Burdenko National medical research center of neurosurgery of the ministry of health of the Russian federation (N.N. Burdenko NMRCN)
🇷🇺Moscow, Russian Federation
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
University Clinic for Traumatology, Orthopedics, Anesthesia, Reanimation, and Intensive Care Medicine
🇲🇰Skopje, North Macedonia
Clinical Emergency Hospital of Bucharest
🇷🇴Bucharest, Romania
Clinical Center of Serbia, Cener for anaestesia , Department for digestive surgery
🇷🇸Belgrade, Serbia
Maastricht UMC+
🇳🇱Maastricht, Netherlands
Emergency Institute for Cardiovascular Diseases "Prof CC Iliescu"
🇷🇴Bucuresti, Romania
Cardiovacular Institute Dedinje
🇷🇸Belgrade, Serbia
Clinic for ENT and maxillofacial surgery, Clinical Center of Serbia
🇷🇸Belgrade, Serbia
NN Blokhin National Medical Cancer Research Center
🇷🇺Moscow, Russian Federation
Baskent University Konya Research Center
🇹🇷Konya, Turkey