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MortalityPOSENCT03152734

Periinterventional Outcome Study in the Elderly

An observational study of Mortality and Complication, Postoperative, run by Mark Coburn at 177 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 80 years and older
Conditions the study is for
Mortality, Complication, Postoperative
What is being tested?
Surgical or non-surgical intervention
Type of treatment
Surgery or procedure
How many people
9,500 participants
Where
177 sitesin 20 countries
Study dates
1 Oct 2017to 30 Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

177 sites in 20 countries.

177 sites in 20 countries

France34 sites

  • CHU Amiens Picardie

    Amiens

  • CHU Angers

    Angers

  • Centre Hospitalier Fleyriat

    Bourg-en-Bresse

  • Centre hospitalier Pierre Oudot

    Bourgoin

  • HIA Clermont Tonnerre

    Brest

  • Hopital d'Instruction des Armées Percy

    Clamart

  • CH Le Mans

    Le Mans

  • Huriez Hospital, University Hospital of Lille

    Lille

  • Clinique de la Sauvegarde

    Lyon

  • Croix Rousse Hospital

    Lyon

  • Hopital Edouard Herriot

    Lyon

  • Hôpital Lyon Sud

    Lyon

  • Neurologic Hospital-Hospices Civils de Lyon

    Lyon

  • AP-HM Hôpital Nord

    Marseille

  • CH Martigues

    Martigues

  • Clinique Saint Jean

    Montpellier

  • Centre Hospitalier Universitaire de Nantes

    Nantes

  • CHU Nantes

    Nantes

  • AP-HP, Hopital Saint-Louis

    Paris

  • Cochin University Hospital

    Paris

  • Hopital de la Pitié-Salpe tri ere

    Paris

  • Hopital Saint Antoine

    Paris

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers

  • Hopital Prive Claude Galien

    Quincy-sous-Sénart

  • University Hospital of Reims

    Reims

  • Clinique Trenel

    Saint-Coulomb

  • CHU Hôpital Nord

    Saint-Etienne

  • Clinique Mutualiste Saint Etienne

    Saint-Etienne

  • Polyclinique de l'atlantique

    Saint-Herblain

  • Groupe Hospitalier Selestat-Obernai

    Sélestat

  • Hopital Foch

    Suresnes

  • Centre Hospitalier de Bigorre

    Tarbes

  • CHU Toulouse

    Toulouse

  • Gustave Roussy Cancer Center

    Villejuif

Other trials in France

Germany21 sites

  • Department of Anesthesiology, University Hospital Aachen

    Aachen, North Rhine-Westphalia, 52074

  • St. Josef- Hospital

    Bochum

  • University Hospital Knappschaftskrankenhaus Bochum

    Bochum

  • University of Bonn

    Bonn

  • University Hospital Carl Gustav Carus Dresden

    Dresden

  • Heinrich-Heine University Duesseldorf

    Düsseldorf

  • University Hospital Frankfurt

    Frankfurt

  • Hannover Medical School

    Hanover

  • Marien Hospital Herne, UK der Ruhr-Universität Bochum

    Herne

  • Jena University Hospital

    Jena

  • Universitätsklinikum Schleswig-Holstein Campus Luebeck

    Lübeck

  • Universitaetsklinikum Marburg

    Marburg

  • Johannes Wesling Klinikum Minden

    Minden

  • Klinikum der Ludwigs-Maximilians-Universität München (LMU)

    München

  • Klinikum rechts der Isar der TU München

    München

  • St. Franziskus-Hospital Münster

    Münster

  • University Hospital Münster

    Münster

  • Klinikum Oldenburg AÖR

    Oldenburg

  • University Hospital Tübingen

    Tübingen

  • Kliniverbund St. Antonius und St. Josef GmbH

    Wuppertal

  • University Hospital of Wuerzburg

    Würzburg

Other trials in Germany

Greece20 sites

  • Democritus University of Thrace

    Alexandroupoli

  • Alexandra Hospital

    Athens

  • Evangelismos General Hospital

    Athens

  • General Hospital of Athens "G. Gennimatas"

    Athens

  • Onassis Cardiac Surgery Center

    Athens

  • Attikon University Hospital

    Chaïdári

  • University Hospital of Ioannina

    Ioannina

  • General Hospital of Kavala

    Kavala

  • Komotini General Hospital

    Komotini

  • University Hospital of Larissa

    Larissa

  • University Hospital of Patras

    Pátrai

  • Tzaneio General Hospital of Pireaus

    Piraeus

  • AHEPA University Hospital

    Thessaloniki

  • General Hospital Papanikolaou

    Thessaloniki

  • George Papanikolaou

    Thessaloniki

  • Hippokrateion General Hospital

    Thessaloniki

  • Medical School, Aristotle University of Thessaloniki

    Thessaloniki

  • Theagenio Cancer Hospital

    Thessaloniki

  • General Hospital of Veroia

    Véroia

  • General Hospital of Volos "Achillopouleio"

    Volos

Other trials in Greece

Turkey (Türkiye)18 sites

  • Ankara University Cebeci Hospital

    Ankara

  • Ankara University Faculty of Medicine-Ibni Sina Hospital

    Ankara

  • Ufuk University Dr. Ridvan Ege Hospital

    Ankara

  • University of Health Sciences Diskapi Yildirim Beyazit Education and Training Hospital

    Ankara

  • Balikesir Atatürk City Hospital

    Balıkesir

  • Kocaeli Derince Training and Research Hospital

    Derince

  • TR Ministry of Health Erzurum Palandoken State Hospital

    Erzurum

  • Baltalimani Metin Sabanci Bone and Joint Diseases Education and Research Hospital

    Istanbul

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

    Istanbul

  • Istanbul University, Istanbul Faculty of Medicine

    Istanbul

  • Marmara University Pendik Training and Research Hospital

    Istanbul

  • Dokuz Eylul University Faculty of Medicine

    Izmir

  • Saglik Bilimleri University Tepecik Education and Research Hospital

    Izmir

  • Baskent University Konya Research Center

    Konya

  • Konya Education and Research Hospital

    Konya

  • RTE university school of medicine

    Rize

  • Sakarya University School od Medicine

    Sakarya

  • Republic of Turkey Ministry of Health Tunceli State Hospital

    Tunceli

Other trials in Turkey (Türkiye)

Spain17 sites

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón

  • Consorci Sanitari Integral

    Barcelona

  • CSI Hospital General de l'Hospitalet

    Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital Universitari Sagrat Cor

    Barcelona

  • Universitary General Hospital of Ciudad Real

    Ciudad Real

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria

  • Hospital of Leon

    León

  • San Pedro Hospital

    Logroño

  • Hospital General Gregorio Maranon

    Madrid

  • Hospital Ramon y Cajal

    Madrid

  • Hospital Universitario Infanta Leonor

    Madrid

  • Hospital Universitario La Princesa

    Madrid

  • Hospital de Sant Joan Despí Moises Broggi - Consorci Sanitari Integral

    Sant Joan Despí

  • Hospital Clinico Universitario

    Valencia

  • Hospital Universitario Araba

    Vitoria-Gasteiz

  • Hospital Universitario Miguel Servet

    Zaragoza

Other trials in Spain

Serbia10 sites

  • Cardiovacular Institute Dedinje

    Belgrade

  • CHC Bezaniska Kosa

    Belgrade

  • Clinic for ENT and maxillofacial surgery, Clinical Center of Serbia

    Belgrade

  • Clinic for orthopedics surgery and traumatology Clinical center of Serbia

    Belgrade

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

    Belgrade

  • Clinical Centre of Serbia

    Belgrade

  • Emergency Center, Clinical Center of Serbia

    Belgrade

  • Urology Hospital, Clinical center of Serbia

    Belgrade

  • Clinical Center Nis

    Niš

  • General Hospital Sremska Mitrovica

    Sremska Mitrovica

Other trials in Serbia

Georgia9 sites

  • Health centre "Medina"

    Batumi

  • 5th General Hospital "Open Heart"

    Tbilisi

  • Acad. N. Kipshidze Central University Clinic

    Tbilisi

  • EVEX Traumatology Hospital

    Tbilisi

  • Medical Corporation Evex, Tbilisi Referral Hospital

    Tbilisi

  • Mediclubgeorgia

    Tbilisi

  • New Hospital

    Tbilisi

  • Oftalmij

    Tbilisi

  • Medical Corporation Evex - Zugdidi Referral Hospital

    Zugdidi

Other trials in Georgia

Belgium7 sites

  • ZNA Middelheim

    Antwerp

  • Universitair Ziekenhuis Antwerpen

    Edegem

  • Ziekenhuis Oost-Limburg

    Genk

  • Ghent University Hospital

    Ghent

  • AZ Groeninge

    Kortrijk

  • University Hospital Leuven

    Leuven

  • AZ Turnhout

    Turnhout

Other trials in Belgium

Denmark7 sites

  • Aarhus Universityhospital

    Aarhus

  • Rigshospitalet, Neuroscience Centre

    Copenhagen

  • Rigshospitalet

    Copenhagen

  • Herlev Hospital

    Herlev

  • Nordsjællands Hospital

    Hillerød

  • Hospital Unit Horsens

    Horsens

  • Hospitaln Lillebælt

    Vejle

Other trials in Denmark

Israel5 sites

  • Shaare Zedek Medical Center

    Jerusalem

  • Galilee Medical Center

    Nahariya

  • Rabin Medical Center Beilinson Hospital

    Petah Tikva

  • Sheba Academic Medical Center

    Ramat Gan

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Romania5 sites

  • Clinical Emergency Hospital of Bucharest

    Bucharest

  • Emergency Institute for Cardiovascular Diseases "Prof CC Iliescu"

    Bucharest

  • Fundeni Clinical Institute

    Bucharest

  • University Emergency Central Military Hospital

    Bucharest

  • Emergency County Hospital Cluj

    Cluj-Napoca

Other trials in Romania

Switzerland5 sites

  • University Hospital Basel

    Basel

  • Kantonsspital Baselland Liestal

    Liestal

  • Hirslanden Clinic St. Anna Lucern

    Lucerne

  • Spital Limmattal

    Schlieren

  • Bürgerspital Solothurn

    Solothurn

Other trials in Switzerland

Netherlands4 sites

  • Albert Schweitzer Hospital

    Dordrecht

  • Maastricht UMC+

    Maastricht

  • Maasstad Ziekenhuis

    Rotterdam

  • University Medical Center Utrecht

    Utrecht

Other trials in Netherlands

Russia4 sites

  • GBUZ Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

    Chelyabinsk

  • 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

  • NN Blokhin National Medical Cancer Research Center

    Moscow

  • P.A. Herzen Moscow Cancer Research Institute

    Moscow

Other trials in Russia

Ireland3 sites

  • Cork University Hospital Group

    Cork

  • St Vincents University Hospital

    Dublin

  • Tallaght Hospital

    Dublin

Other trials in Ireland

Portugal3 sites

  • Centro Hospitalar e Universitario de Coimbra

    Coimbra

  • Centro Hospitalar Lisboa Norte - Hospital Santa Maria

    Lisbon

  • Centro Hospitalar Tamega e Sousa

    Penafiel

Other trials in Portugal

North Macedonia2 sites

  • University Clinic for Gyn & Ob / Clinical Center Mother Teresa

    Skopje

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

    Skopje

Other trials in North Macedonia

Austria1 site

  • University Hospital Salzburg

    Salzburg

Other trials in Austria

Poland1 site

  • Jagiellonian University Medical College

    Krakow

Other trials in Poland

Ukraine1 site

  • Zaporizhzhia State Medical University

    Zaporizhzhya

Other trials in Ukraine

About this study

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

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.

Read the 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.

Being tested
Surgical or non-surgical intervention
Keywords
Elderly patients, Mortality, morbidity, post-intervention
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgical or non-surgical interventionProcedure or surgery

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

Study groups in NCT03152734
Study groupRoleWhat they receive
Elderly patientElderly patient undergoing surgical and non-surgical intervention with the use of anesthesia provided by an anesthetist
Receives: Procedure: Surgical or non-surgical intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Number of patients with death from any cause

    Measured: From intervention until day 30.

Secondary outcomes (29)

  1. In-hospital outcome according to the ACS National Surgical Quality Improvement Program® (ACS NSQIP®)

    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

    Measured: From intervention until day 30.

  2. Analysis of the new-onset of serious cardiac complications

    Number of patients with serious cardiac complication

    Cardiac complication is defined according to the American Heart Association

    Measured: From intervention up to 30-days after intervention

  3. Analysis of the new-onset of serious pulmonary complications

    Number of patients with

    • Pneumonia: Clinical or radiological diagnosis. or
    • Pulmonary embolism: Radiological diagnosis. Signs of pneumonia or pulmonary embolism in the autopsy

    Measured: From intervention up to 30-days after intervention

  4. Analysis of the new-onset of acute stroke

    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.

    Measured: From intervention up to 30-days after intervention

  5. Analysis of the new-onset of acute kidney injury

    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.

    Measured: From intervention up to 30-days after intervention

  6. Unplanned intensive care unit admission

    Number of patients

    Measured: From intervention until hospital discharge or maximum 30-days after intervention

  7. Unplanned intubation after intervention

    Number of patients

    Measured: From intervention until hospital discharge or maximum 30-days after intervention

  8. Hospital discharge destination

    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.

    Measured: From intervention until hospital discharge or maximum 30-days after intervention

  9. Perioperative admission to a unit with a geriatric care model

    Number of patients, which are post-interventionally admitted to e.g. geriatric units, geriatric co-management models, geriatric liaison services

    Measured: From intervention until hospital discharge or maximum 30-days after intervention

  10. Patient's functional status of independency

    Scale assessed by interview of the patient according to the NSQIP (Independent, partially dependent, totally dependent).

    Measured: On day 30 after intervention

  11. Brief screen for cognitive impairment

    Number of correct recall of three words (Brief Screen for Cognitive Impairment test)

    Measured: On day 30 after intervention

  12. Comparing the postoperative in-hospital and 30-day outcome with preoperatively via NSQIP risk calculator and POSPOM predicted outcome for surgeries

    Comparing the number of via preoperative NSQIP risk calculator and POSPOM predicted outcomes with the number of postoperative outcomes of the patient

    Measured: On day 30 after intervention

  13. Number of used intra-interventional monitoring for elderly patients in the clinical routine

    Number of patients, where a specific monitoring device was intra-interventionally used

    Measured: Intra-interventional

  14. Number of patients with premedication

    Number of patients with premedication given before intervention.

    Measured: Intra-interventional

  15. Type of anesthesia technique

    Number of patients with a specific type of anesthesia technique (e.g. spinal, general etc)

    Measured: Intra-interventional

  16. Type of the main anesthetic

    Number of patients with a specific type of anesthesia drugs (e.g. desflurane, isoflurane etc.)

    Measured: Intra-interventional

  17. Type of the main intra-interventional opioid

    Number of patients with a specific type of opioid for anesthesia (e.g. fentanyl etc.)

    Measured: Intra-interventional

  18. Anesthesia duration

    Begin to end of anesthesia for intervention

    Measured: Intra-interventional

  19. Amount of intra-interventionally transfused blood and blood products

    e.g. transfusion of packed red blood cells, fresh frozen plasmas and platelets

    Measured: Intra-interventional

  20. Number of extubated patients

    At the end of intervention

    Measured: Intra-interventional

  21. Kind of intervention

    Surgical procedure category, severity, urgency, wound class

    Measured: Intra-interventional

  22. Use of WHO safe surgery checklist

    Number of patients , where the WHO safe surgery checklist was used

    Measured: Intra-interventional

  23. Kind of referring facility

    Number of patients referred from home,other hospital, rehabilitation, nursing home or other referring facility, respectively.

    Measured: Pre-interventional at baseline visit

  24. Amount of pre-interventional comorbidities

    Number of comorbidities

    Measured: pre-interventional at baseline visit

  25. Albumin and hematocrit level before intervention

    Optional assessment, only if done in the clinical routine

    Measured: pre-interventional at baseline visit

  26. Number of falls in the last 6 months

    Number of falls per patient

    Measured: pre-interventional at baseline visit

  27. Mini-Cog (for the cognitive status)

    Performance of the mini-cog test and analysis of the maximum points in this test

    Measured: pre-interventional at baseline visit

  28. Pre-interventional timed "Up & Go" test

    Seconds to perform the up and go test will be measured

    Measured: pre-interventional at baseline visit

  29. Comparison of the patients' outcomes across Europe

    Comparing the number of adverse outcomes between the hospitals and countries

    Measured: 30 days after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2017
  2. Study start1 Oct 2017
  3. Primary completion30 Jan 2019
  4. Study completion30 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
9,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03152734
Sponsor's protocol ID
17-070
Acronym
POSE
Status last verified
Nov 2019
First submitted
9 May 2017
Last updated
20 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39916969

  • 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.

    PubMed 34817420

  • 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.

    PubMed 34799496

Questions about this trial

What is this clinical trial studying?

An observational study of Mortality and Complication, Postoperative, run by Mark Coburn at 177 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in France, Germany, Greece, Turkey (Türkiye), Spain and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peri-interventional (surgical and non-surgical interventional) all-cause mortality rate on day 30 (time frame: From intervention until day 30.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03152734, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.

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