Periinterventional Outcome Study in the Elderly

NCT ID: NCT03152734

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-01-30

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.

Conditions

Mortality; Complication, Postoperative

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Elderly patient

Elderly patient undergoing surgical and non-surgical intervention with the use of anesthesia provided by an anesthetist

Surgical or non-surgical intervention

Intervention Type: PROCEDURE

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

Interventions

Surgical or non-surgical intervention

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mark Coburn

OTHER

Sponsor Role: lead

Responsible Party

Mark Coburn

Prof. Dr. med. Mark Coburn

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mark Coburn, MD

Role: STUDY_CHAIR

Department of Anesthesiology, University Hospital Aachen, Germany

Locations

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

Rigshospitalet

Copenhagen, , Denmark

Herlev Hospital

Herlev, , Denmark

Nordsjællands Hospital

Hillerød, , Denmark

Hospital Unit Horsens

Horsens, , Denmark

Hospitaln Lillebælt

Vejle, , Denmark

CHU Amiens Picardie

Amiens, , France

CHU Angers

Angers, , France

Centre Hospitalier Fleyriat

Bourg-en-Bresse, , France

Centre hospitalier Pierre Oudot

Bourgoin, , France

HIA Clermont Tonnerre

Brest, , France

Hopital d'Instruction des Armées Percy

Clamart, , France

CH Le Mans

Le Mans, , France

Huriez Hospital, University Hospital of Lille

Lille, , France

Clinique de la Sauvegarde

Lyon, , France

Croix Rousse Hospital

Lyon, , France

Hopital Edouard Herriot

Lyon, , France

Hôpital Lyon Sud

Lyon, , France

Neurologic Hospital-Hospices Civils de Lyon

Lyon, , France

AP-HM Hôpital Nord

Marseille, , France

CH Martigues

Martigues, , France

Clinique Saint Jean

Montpellier, , France

Centre Hospitalier Universitaire de Nantes

Nantes, , France

CHU Nantes

Nantes, , France

AP-HP, Hopital Saint-Louis

Paris, , France

Cochin University Hospital

Paris, , France

Hopital de la Pitié-Salpe tri ere

Paris, , France

Hopital Saint Antoine

Paris, , France

Centre Hospitalier Universitaire de Poitiers

Poitiers, , France

Hopital Prive Claude Galien

Quincy-sous-Sénart, , France

University Hospital of Reims

Reims, , France

Clinique Trenel

Saint-Coulomb, , France

CHU Hôpital Nord

Saint-Etienne, , France

Clinique Mutualiste Saint Etienne

Saint-Etienne, , France

Polyclinique de l'atlantique

Saint-Herblain, , France

Groupe Hospitalier Selestat-Obernai

Sélestat, , France

Hopital Foch

Suresnes, , France

Centre Hospitalier de Bigorre

Tarbes, , France

CHU Toulouse

Toulouse, , 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

EVEX Traumatology Hospital

Tbilisi, , Georgia

Medical Corporation Evex, Tbilisi Referral Hospital

Tbilisi, , Georgia

Mediclubgeorgia

Tbilisi, , Georgia

New Hospital

Tbilisi, , Georgia

Oftalmij

Tbilisi, , Georgia

Medical Corporation Evex - Zugdidi Referral Hospital

Zugdidi, , Georgia

Department of Anesthesiology, University Hospital Aachen

Aachen, North Rhine-Westphalia, Germany

St. Josef- Hospital

Bochum, , Germany

University Hospital Knappschaftskrankenhaus Bochum

Bochum, , Germany

University of Bonn

Bonn, , Germany

University Hospital Carl Gustav Carus Dresden

Dresden, , Germany

Heinrich-Heine University Duesseldorf

Düsseldorf, , Germany

University Hospital Frankfurt

Frankfurt, , Germany

Hannover Medical School

Hanover, , Germany

Marien Hospital Herne, UK der Ruhr-Universität Bochum

Herne, , Germany

Jena University Hospital

Jena, , Germany

Universitätsklinikum Schleswig-Holstein Campus Luebeck

Lübeck, , Germany

Universitaetsklinikum Marburg

Marburg, , Germany

Johannes Wesling Klinikum Minden

Minden, , Germany

Klinikum der Ludwigs-Maximilians-Universität München (LMU)

München, , Germany

Klinikum rechts der Isar der TU München

München, , Germany

St. Franziskus-Hospital Münster

Münster, , Germany

University Hospital Münster

Münster, , Germany

Klinikum Oldenburg AÖR

Oldenburg, , Germany

University Hospital Tübingen

Tübingen, , Germany

Kliniverbund St. Antonius und St. Josef GmbH

Wuppertal, , Germany

University Hospital of Wuerzburg

Würzburg, , Germany

Democritus University of Thrace

Alexandroupoli, , Greece

Alexandra Hospital

Athens, , Greece

Evangelismos General Hospital

Athens, , Greece

General Hospital of Athens "G. Gennimatas"

Athens, , Greece

Onassis Cardiac Surgery Center

Athens, , Greece

Attikon University Hospital

Chaïdári, , Greece

University Hospital of Ioannina

Ioannina, , Greece

General Hospital of Kavala

Kavala, , Greece

Komotini General Hospital

Komotini, , Greece

University Hospital of Larissa

Larissa, , Greece

University Hospital of Patras

Pátrai, , Greece

Tzaneio General Hospital of Pireaus

Piraeus, , Greece

AHEPA University Hospital

Thessaloniki, , Greece

General Hospital Papanikolaou

Thessaloniki, , Greece

George Papanikolaou

Thessaloniki, , Greece

Hippokrateion General Hospital

Thessaloniki, , Greece

Medical School, Aristotle University of Thessaloniki

Thessaloniki, , Greece

Theagenio Cancer Hospital

Thessaloniki, , Greece

General Hospital of Veroia

Véroia, , Greece

General Hospital of Volos "Achillopouleio"

Volos, , Greece

Cork University Hospital Group

Cork, , Ireland

St Vincents University Hospital

Dublin, , Ireland

Tallaght Hospital

Dublin, , Ireland

Shaare Zedek Medical Center

Jerusalem, , Israel

Galilee Medical Center

Nahariya, , Israel

Rabin Medical Center Beilinson Hospital

Petah Tikva, , Israel

Sheba Academic Medical Center

Ramat Gan, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Albert Schweitzer Hospital

Dordrecht, , Netherlands

Maastricht UMC+

Maastricht, , Netherlands

Maasstad Ziekenhuis

Rotterdam, , Netherlands

University Medical Center Utrecht

Utrecht, , Netherlands

University Clinic for Gyn & Ob / Clinical Center Mother Teresa

Skopje, , North Macedonia

University Clinic for Traumatology, Orthopedics, Anesthesia, Reanimation, and Intensive Care Medicine

Skopje, , North Macedonia

Jagiellonian University Medical College

Krakow, , Poland

Centro Hospitalar e Universitario de Coimbra

Coimbra, , Portugal

Centro Hospitalar Lisboa Norte - Hospital Santa Maria

Lisbon, , Portugal

Centro Hospitalar Tamega e Sousa

Penafiel, , Portugal

Clinical Emergency Hospital of Bucharest

Bucharest, , Romania

Emergency Institute for Cardiovascular Diseases "Prof CC Iliescu"

Bucharest, , Romania

Fundeni Clinical Institute

Bucharest, , Romania

University Emergency Central Military Hospital

Bucharest, , Romania

Emergency County Hospital Cluj

Cluj-Napoca, , Romania

GBUZ Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

Chelyabinsk, , Russia

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, , Russia

NN Blokhin National Medical Cancer Research Center

Moscow, , Russia

P.A. Herzen Moscow Cancer Research Institute

Moscow, , Russia

Cardiovacular Institute Dedinje

Belgrade, , Serbia

CHC Bezaniska Kosa

Belgrade, , Serbia

Clinic for ENT and maxillofacial surgery, Clinical Center of Serbia

Belgrade, , Serbia

Clinic for orthopedics surgery and traumatology Clinical center of Serbia

Belgrade, , Serbia

Clinical Center of Serbia, Cener for anaestesia , Department for digestive surgery

Belgrade, , Serbia

Clinical Centre of Serbia

Belgrade, , Serbia

Emergency Center, Clinical Center of Serbia

Belgrade, , Serbia

Urology Hospital, Clinical center of Serbia

Belgrade, , Serbia

Clinical Center Nis

Niš, , Serbia

General Hospital Sremska Mitrovica

Sremska Mitrovica, , Serbia

Hospital Universitario Fundacion Alcorcon

Alcorcón, , Spain

Consorci Sanitari Integral

Barcelona, , Spain

CSI Hospital General de l'Hospitalet

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitari Sagrat Cor

Barcelona, , Spain

Universitary General Hospital of Ciudad Real

Ciudad Real, , Spain

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, , Spain

Hospital of Leon

León, , Spain

San Pedro Hospital

Logroño, , Spain

Hospital General Gregorio Maranon

Madrid, , Spain

Hospital Ramon y Cajal

Madrid, , Spain

Hospital Universitario Infanta Leonor

Madrid, , Spain

Hospital Universitario La Princesa

Madrid, , Spain

Hospital de Sant Joan Despí Moises Broggi - Consorci Sanitari Integral

Sant Joan Despí, , Spain

Hospital Clinico Universitario

Valencia, , Spain

Hospital Universitario Araba

Vitoria-Gasteiz, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , 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 Cebeci Hospital

Ankara, , Turkey (Türkiye)

Ankara University Faculty of Medicine-Ibni Sina Hospital

Ankara, , Turkey (Türkiye)

Ufuk University Dr. Ridvan Ege Hospital

Ankara, , Turkey (Türkiye)

University of Health Sciences Diskapi Yildirim Beyazit Education and Training Hospital

Ankara, , Turkey (Türkiye)

Balikesir Atatürk City Hospital

Balıkesir, , Turkey (Türkiye)

Kocaeli Derince Training and Research Hospital

Derince, , Turkey (Türkiye)

TR Ministry of Health Erzurum Palandoken State Hospital

Erzurum, , Turkey (Türkiye)

Baltalimani Metin Sabanci Bone and Joint Diseases Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Marmara University Pendik Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Dokuz Eylul University Faculty of Medicine

Izmir, , Turkey (Türkiye)

Saglik Bilimleri University Tepecik Education and Research Hospital

Izmir, , Turkey (Türkiye)

Baskent University Konya Research Center

Konya, , Turkey (Türkiye)

Konya Education and Research Hospital

Konya, , Turkey (Türkiye)

RTE university school of medicine

Rize, , Turkey (Türkiye)

Sakarya University School od Medicine

Sakarya, , Turkey (Türkiye)

Republic of Turkey Ministry of Health Tunceli State Hospital

Tunceli, , Turkey (Türkiye)

Zaporizhzhia State Medical University

Zaporizhzhya, , Ukraine

Countries

Austria; Belgium; Denmark; France; Georgia; Germany; Greece; Ireland; Israel; Netherlands; North Macedonia; Poland; Portugal; Romania; Russia; Serbia; Spain; Switzerland; Turkey (Türkiye); Ukraine

References

Hoogma DF, Al Tmimi L, Fieuws S, Tournoy J, Kowark A, Rossaint R, Coburn M, Rex S. Circadian effect of time of anaesthesia on postoperative outcomes in major elective and urgent intervention: a secondary analysis of the Peri-interventional Outcome Study in the Elderly (POSE). Eur J Anaesthesiol Intensive Care. 2022 Aug 24;1(3):e005. doi: 10.1097/EA9.0000000000000005. eCollection 2022 Jun.

Reference Type: DERIVED

PMID: 39916969 (View on PubMed)

Kowark A, Berger M, Rossaint R, Schmid M, Coburn M; POSE-Study group. Association between benzodiazepine premedication and 30-day mortality rate: A propensity-score weighted analysis of the Peri-interventional Outcome Study in the Elderly (POSE). Eur J Anaesthesiol. 2022 Mar 1;39(3):210-218. doi: 10.1097/EJA.0000000000001638.

Reference Type: DERIVED

PMID: 34817420 (View on PubMed)

POSE-Study group. Peri-interventional outcome study in the elderly in Europe: A 30-day prospective cohort study. Eur J Anaesthesiol. 2022 Mar 1;39(3):198-209. doi: 10.1097/EJA.0000000000001639.

Reference Type: DERIVED

PMID: 34799496 (View on PubMed)

Other Identifiers

17-070

Identifier Type: -

Identifier Source: org_study_id