Periinterventional Outcome Study in the Elderly

NCT03152734 | Completed

• 1 other identifier: 17-070
• Study Type: observational
• Target: 9,500
• Locations: 20 countries
• Sites: 177

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.

Conditions

Mortality; Complication, Postoperative

Keywords

Elderly patients, Mortality, morbidity, post-intervention

Outcome Measures

Primary Outcomes (1)

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

  Number of patients with death from any cause

  From intervention until day 30.

Secondary Outcomes (29)

• 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 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

• Analysis of the new-onset of acute kidney injury

  From intervention up to 30-days after intervention

Other Outcomes (5)

• Age and gender-effect on the 30 day mortality

  30 days after intervention

• Effect of pre-interventional morbidities on the 30 day mortality

  30 days after intervention

• Effect of type of surgery or non-surgical intervention on the 30 day mortality

  30 days after intervention

Study Arms (1)

Elderly patient

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

Procedure: Surgical or non-surgical intervention

Interventions

Surgical or non-surgical intervention PROCEDURE

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

Elderly patient

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be selected from secondary and tertiary hospitals in several countries in Europe.

You may qualify if:

• Age ≥ 80 years
• Written informed consent according to the national law requirements
• Elective and emergency procedures
• In-patient and out-patient procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• Mark Coburn: lead

Study Sites (177)

University Hospital Salzburg

Salzburg, Austria

Location

ZNA Middelheim

Antwerp, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

Ghent University Hospital

Ghent, Belgium

Location

AZ Groeninge

Kortrijk, Belgium

Location

University Hospital Leuven

Leuven, Belgium

Location

AZ Turnhout

Turnhout, Belgium

Location

Aarhus Universityhospital

Aarhus, Denmark

Location

Rigshospitalet, Neuroscience Centre

Copenhagen, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Herlev Hospital

Herlev, Denmark

Location

Nordsjællands Hospital

Hillerød, Denmark

Location

Hospital Unit Horsens

Horsens, Denmark

Location

Hospitaln Lillebælt

Vejle, Denmark

Location

CHU Amiens Picardie

Amiens, France

Location

CHU Angers

Angers, France

Location

Centre Hospitalier Fleyriat

Bourg-en-Bresse, France

Location

Centre hospitalier Pierre Oudot

Bourgoin, France

Location

HIA Clermont Tonnerre

Brest, France

Location

Hopital d'Instruction des Armées Percy

Clamart, France

Location

CH Le Mans

Le Mans, France

Location

Huriez Hospital, University Hospital of Lille

Lille, France

Location

Clinique de la Sauvegarde

Lyon, France

Location

Croix Rousse Hospital

Lyon, France

Location

Hopital Edouard Herriot

Lyon, France

Location

Hôpital Lyon Sud

Lyon, France

Location

Neurologic Hospital-Hospices Civils de Lyon

Lyon, France

Location

AP-HM Hôpital Nord

Marseille, France

Location

CH Martigues

Martigues, France

Location

Clinique Saint Jean

Montpellier, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, France

Location

CHU Nantes

Nantes, France

Location

AP-HP, Hopital Saint-Louis

Paris, France

Location

Cochin University Hospital

Paris, France

Location

Hopital de la Pitié-Salpe tri ere

Paris, France

Location

Hopital Saint Antoine

Paris, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

Location

Hopital Prive Claude Galien

Quincy-sous-Sénart, France

Location

University Hospital of Reims

Reims, France

Location

Clinique Trenel

Saint-Coulomb, France

Location

CHU Hôpital Nord

Saint-Etienne, France

Location

Clinique Mutualiste Saint Etienne

Saint-Etienne, France

Location

Polyclinique de l'atlantique

Saint-Herblain, France

Location

Groupe Hospitalier Selestat-Obernai

Sélestat, France

Location

Hopital Foch

Suresnes, France

Location

Centre Hospitalier de Bigorre

Tarbes, France

Location

CHU Toulouse

Toulouse, France

Location

Gustave Roussy Cancer Center

Villejuif, France

Location

Health centre "Medina"

Batumi, Georgia

Location

5th General Hospital "Open Heart"

Tbilisi, Georgia

Location

Acad. N. Kipshidze Central University Clinic

Tbilisi, Georgia

Location

EVEX Traumatology Hospital

Tbilisi, Georgia

Location

Medical Corporation Evex, Tbilisi Referral Hospital

Tbilisi, Georgia

Location

Mediclubgeorgia

Tbilisi, Georgia

Location

New Hospital

Tbilisi, Georgia

Location

Oftalmij

Tbilisi, Georgia

Location

Medical Corporation Evex - Zugdidi Referral Hospital

Zugdidi, Georgia

Location

Department of Anesthesiology, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

St. Josef- Hospital

Bochum, Germany

Location

University Hospital Knappschaftskrankenhaus Bochum

Bochum, Germany

Location

University of Bonn

Bonn, Germany

Location

University Hospital Carl Gustav Carus Dresden

Dresden, Germany

Location

Heinrich-Heine University Duesseldorf

Düsseldorf, Germany

Location

University Hospital Frankfurt

Frankfurt, Germany

Location

Hannover Medical School

Hanover, Germany

Location

Marien Hospital Herne, UK der Ruhr-Universität Bochum

Herne, Germany

Location

Jena University Hospital

Jena, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Luebeck

Lübeck, Germany

Location

Universitaetsklinikum Marburg

Marburg, Germany

Location

Johannes Wesling Klinikum Minden

Minden, Germany

Location

Klinikum der Ludwigs-Maximilians-Universität München (LMU)

München, Germany

Location

Klinikum rechts der Isar der TU München

München, Germany

Location

St. Franziskus-Hospital Münster

Münster, Germany

Location

University Hospital Münster

Münster, Germany

Location

Klinikum Oldenburg AÖR

Oldenburg, Germany

Location

University Hospital Tübingen

Tübingen, Germany

Location

Kliniverbund St. Antonius und St. Josef GmbH

Wuppertal, Germany

Location

University Hospital of Wuerzburg

Würzburg, Germany

Location

Democritus University of Thrace

Alexandroupoli, Greece

Location

Alexandra Hospital

Athens, Greece

Location

Evangelismos General Hospital

Athens, Greece

Location

General Hospital of Athens "G. Gennimatas"

Athens, Greece

Location

Onassis Cardiac Surgery Center

Athens, Greece

Location

Attikon University Hospital

Chaïdári, Greece

Location

University Hospital of Ioannina

Ioannina, Greece

Location

General Hospital of Kavala

Kavala, Greece

Location

Komotini General Hospital

Komotini, Greece

Location

University Hospital of Larissa

Larissa, Greece

Location

University Hospital of Patras

Pátrai, Greece

Location

Tzaneio General Hospital of Pireaus

Piraeus, Greece

Location

AHEPA University Hospital

Thessaloniki, Greece

Location

General Hospital Papanikolaou

Thessaloniki, Greece

Location

George Papanikolaou

Thessaloniki, Greece

Location

Hippokrateion General Hospital

Thessaloniki, Greece

Location

Medical School, Aristotle University of Thessaloniki

Thessaloniki, Greece

Location

Theagenio Cancer Hospital

Thessaloniki, Greece

Location

General Hospital of Veroia

Véroia, Greece

Location

General Hospital of Volos "Achillopouleio"

Volos, Greece

Location

Cork University Hospital Group

Cork, Ireland

Location

St Vincents University Hospital

Dublin, Ireland

Location

Tallaght Hospital

Dublin, Ireland

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Galilee Medical Center

Nahariya, Israel

Location

Rabin Medical Center Beilinson Hospital

Petah Tikva, Israel

Location

Sheba Academic Medical Center

Ramat Gan, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Albert Schweitzer Hospital

Dordrecht, Netherlands

Location

Maastricht UMC+

Maastricht, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

University Clinic for Gyn & Ob / Clinical Center Mother Teresa

Skopje, North Macedonia

Location

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

Skopje, North Macedonia

Location

Jagiellonian University Medical College

Krakow, Poland

Location

Centro Hospitalar e Universitario de Coimbra

Coimbra, Portugal

Location

Centro Hospitalar Lisboa Norte - Hospital Santa Maria

Lisbon, Portugal

Location

Centro Hospitalar Tamega e Sousa

Penafiel, Portugal

Location

Clinical Emergency Hospital of Bucharest

Bucharest, Romania

Location

Emergency Institute for Cardiovascular Diseases "Prof CC Iliescu"

Bucharest, Romania

Location

Fundeni Clinical Institute

Bucharest, Romania

Location

University Emergency Central Military Hospital

Bucharest, Romania

Location

Emergency County Hospital Cluj

Cluj-Napoca, Romania

Location

GBUZ Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

Chelyabinsk, Russia

Location

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

Location

NN Blokhin National Medical Cancer Research Center

Moscow, Russia

Location

P.A. Herzen Moscow Cancer Research Institute

Moscow, Russia

Location

Cardiovacular Institute Dedinje

Belgrade, Serbia

Location

CHC Bezaniska Kosa

Belgrade, Serbia

Location

Clinic for ENT and maxillofacial surgery, Clinical Center of Serbia

Belgrade, Serbia

Location

Clinic for orthopedics surgery and traumatology Clinical center of Serbia

Belgrade, Serbia

Location

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

Belgrade, Serbia

Location

Clinical Centre of Serbia

Belgrade, Serbia

Location

Emergency Center, Clinical Center of Serbia

Belgrade, Serbia

Location

Urology Hospital, Clinical center of Serbia

Belgrade, Serbia

Location

Clinical Center Nis

Niš, Serbia

Location

General Hospital Sremska Mitrovica

Sremska Mitrovica, Serbia

Location

Hospital Universitario Fundacion Alcorcon

Alcorcón, Spain

Location

Consorci Sanitari Integral

Barcelona, Spain

Location

CSI Hospital General de l'Hospitalet

Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Universitari Sagrat Cor

Barcelona, Spain

Location

Universitary General Hospital of Ciudad Real

Ciudad Real, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Spain

Location

Hospital of Leon

León, Spain

Location

San Pedro Hospital

Logroño, Spain

Location

Hospital General Gregorio Maranon

Madrid, Spain

Location

Hospital Ramon y Cajal

Madrid, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, Spain

Location

Hospital Universitario La Princesa

Madrid, Spain

Location

Hospital de Sant Joan Despí Moises Broggi - Consorci Sanitari Integral

Sant Joan Despí, Spain

Location

Hospital Clinico Universitario

Valencia, Spain

Location

Hospital Universitario Araba

Vitoria-Gasteiz, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

University Hospital Basel

Basel, Switzerland

Location

Kantonsspital Baselland Liestal

Liestal, Switzerland

Location

Hirslanden Clinic St. Anna Lucern

Lucerne, Switzerland

Location

Spital Limmattal

Schlieren, Switzerland

Location

Bürgerspital Solothurn

Solothurn, Switzerland

Location

Ankara University Cebeci Hospital

Ankara, Turkey (Türkiye)

Location

Ankara University Faculty of Medicine-Ibni Sina Hospital

Ankara, Turkey (Türkiye)

Location

Ufuk University Dr. Ridvan Ege Hospital

Ankara, Turkey (Türkiye)

Location

University of Health Sciences Diskapi Yildirim Beyazit Education and Training Hospital

Ankara, Turkey (Türkiye)

Location

Balikesir Atatürk City Hospital

Balıkesir, Turkey (Türkiye)

Location

Kocaeli Derince Training and Research Hospital

Derince, Turkey (Türkiye)

Location

TR Ministry of Health Erzurum Palandoken State Hospital

Erzurum, Turkey (Türkiye)

Location

Baltalimani Metin Sabanci Bone and Joint Diseases Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

Istanbul University, Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Dokuz Eylul University Faculty of Medicine

Izmir, Turkey (Türkiye)

Location

Saglik Bilimleri University Tepecik Education and Research Hospital

Izmir, Turkey (Türkiye)

Location

Baskent University Konya Research Center

Konya, Turkey (Türkiye)

Location

Konya Education and Research Hospital

Konya, Turkey (Türkiye)

Location

RTE university school of medicine

Rize, Turkey (Türkiye)

Location

Sakarya University School od Medicine

Sakarya, Turkey (Türkiye)

Location

Republic of Turkey Ministry of Health Tunceli State Hospital

Tunceli, Turkey (Türkiye)

Location

Zaporizhzhia State Medical University

Zaporizhzhya, Ukraine

Location

Related Publications (3)

• 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.

  PMID: 39916969 DERIVED

• 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.

  PMID: 34817420 DERIVED

• 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.

  PMID: 34799496 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Coburn, MD

  Department of Anesthesiology, University Hospital Aachen, Germany

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Mark Coburn

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 15, 2017
• Study Start: October 1, 2017
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (20); PL (1); IE (3); TU (18); RO (5); PT (3); SE (10); CH (5); BE (7); NL (4); ES (17); UA (1); FR (34); IL (5); DE (21); GE (9); AU (1); DK (7); NO (2); RU (4)