Periinterventional Outcome Study in the Elderly (POSE)

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.

Study Overview

• Status: Completed
• Conditions: Mortality; Complication, Postoperative
• Intervention / Treatment: Procedure: Surgical or non-surgical intervention

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 Type: Observational
• Enrollment (Actual): 9500

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria
    • University Hospital Salzburg
• Belgium
  • Antwerpen, Belgium
    • ZNA Middelheim
  • Edegem, Belgium
    • Universitair Ziekenhuis Antwerpen
  • Genk, Belgium
    • Ziekenhuis Oost-Limburg
  • Gent, Belgium
    • Ghent University Hospital
  • Kortrijk, Belgium
    • AZ Groeninge
  • Leuven, Belgium
    • University Hospital Leuven
  • Turnhout, Belgium
    • Az Turnhout
• Denmark
  • Aarhus, Denmark
    • Aarhus Universityhospital
  • Copenhagen, Denmark
    • Rigshospitalet
  • Copenhagen, Denmark
    • Rigshospitalet, Neuroscience Centre
  • Herlev, Denmark
    • Herlev Hospital
  • Hillerød, Denmark
    • Nordsjællands Hospital
  • Horsens, Denmark
    • Hospital Unit Horsens
  • Vejle, Denmark
    • Hospitaln Lillebælt
• France
  • Amiens, France
    • CHU Amiens Picardie
  • Angers, France
    • Chu Angers
  • Bourg-en-Bresse, France
    • Centre Hospitalier Fleyriat
  • Bourgoin-Jallieu, France
    • Centre Hospitalier Pierre Oudot
  • Brest, France
    • HIA Clermont Tonnerre
  • Clamart, France
    • Hôpital d'instruction des armées Percy
  • Le Mans, France
    • CH Le Mans
  • Lille, France
    • Huriez Hospital, University Hospital of Lille
  • Lyon, France
    • Hôpital Edouard Herriot
  • Lyon, France
    • Clinique de la Sauvegarde
  • Lyon, France
    • Hopital Lyon Sud
  • Lyon, France
    • Croix Rousse Hospital
  • Lyon, France
    • Neurologic Hospital-Hospices Civils de Lyon
  • Marseille, France
    • AP-HM Hopital Nord
  • Martigues, France
    • CH Martigues
  • Montpellier, France
    • Clinique Saint Jean
  • Nantes, France
    • Chu Nantes
  • Nantes, France
    • Centre Hospitalier Universitaire de Nantes
  • Paris, France
    • Hôpital Saint Antoine
  • Paris, France
    • Cochin University Hospital
  • Paris, France
    • AP-HP, Hôpital Saint-Louis
  • Paris, France
    • Hopital de la Pitié-Salpe tri ere
  • Poitiers, France
    • Centre Hospitalier Universitaire de Poitiers
  • Quincy-sous-Sénart, France
    • Hôpital privé Claude Galien
  • Reims, France
    • University Hospital of Reims
  • Saint-Herblain, France
    • Polyclinique de l'Atlantique
  • Saint-Étienne, France
    • CHU Hopital Nord
  • Saint-Étienne, France
    • Clinique Mutualiste Saint Etienne
  • St Coulomb, France
    • Clinique Trenel
  • Suresnes, France
    • Hôpital Foch
  • Sélestat, France
    • Groupe Hospitalier Selestat-Obernai
  • Tarbes, France
    • Centre Hospitalier de Bigorre
  • Toulouse, France
    • Chu Toulouse
  • Villejuif, France
    • Gustave Roussy Cancer Center
• Georgia
  • Batumi, Georgia
    • Health centre "Medina"
  • Tbilisi, 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
  • Zugdidi, Georgia
    • Medical Corporation Evex - Zugdidi Referral Hospital
• Germany
  • Bochum, Germany
    • St. Josef- Hospital
  • Bochum, Germany
    • University Hospital Knappschaftskrankenhaus Bochum
  • Bonn, Germany
    • University of Bonn
  • Dresden, Germany
    • University Hospital Carl Gustav Carus Dresden
  • Duesseldorf, Germany
    • Heinrich-Heine University Duesseldorf
  • Frankfurt, Germany
    • University Hospital Frankfurt
  • Hannover, Germany
    • Hannover Medical School
  • Herne, Germany
    • Marien Hospital Herne, UK der Ruhr-Universität Bochum
  • Jena, Germany
    • Jena University Hospital
  • Luebeck, Germany
    • Universitätsklinikum Schleswig-Holstein Campus Luebeck
  • Marburg, Germany
    • Universitaetsklinikum Marburg
  • Minden, Germany
    • Johannes Wesling Klinikum Minden
  • Muenchen, Germany
    • Klinikum der Ludwigs-Maximilians-Universität München (LMU)
  • Muenchen, Germany
    • Klinikum rechts der Isar der TU München
  • Münster, Germany
    • University Hospital Münster
  • Münster, Germany
    • St. Franziskus-Hospital Münster
  • Oldenburg, Germany
    • Klinikum Oldenburg AöR
  • Tuebingen, Germany
    • University Hospital Tübingen
  • Wuppertal, Germany
    • Kliniverbund St. Antonius und St. Josef GmbH
  • Würzburg, Germany
    • University Hospital of Wuerzburg
  • NRW
    • Aachen, NRW, Germany, 52074
      • Department of Anesthesiology, University Hospital Aachen
• Greece
  • Alexandroupolis, Greece
    • Democritus University of Thrace
  • Athens, Greece
    • Alexandra Hospital
  • Athens, Greece
    • Evangelismos General Hospital
  • Athens, Greece
    • General Hospital of Athens "G. Gennimatas"
  • Athens, Greece
    • Onassis Cardiac Surgery Center
  • Chaïdári, Greece
    • Attikon University Hospital
  • Ioánnina, Greece
    • University Hospital of Ioannina
  • Kavála, Greece
    • General Hospital of Kavala
  • Komotiní, Greece
    • Komotini General Hospital
  • Larissa, Greece
    • University Hospital of Larissa
  • Patra, Greece
    • University Hospital of Patras
  • Piraeus, Greece
    • Tzaneio General Hospital of Pireaus
  • Thessaloníki, Greece
    • Ahepa University Hospital
  • Thessaloníki, Greece
    • General Hospital Papanikolaou
  • Thessaloníki, Greece
    • George Papanikolaou
  • Thessaloníki, Greece
    • Hippokrateion General Hospital
  • Thessaloníki, Greece
    • Medical School, Aristotle University of Thessaloniki
  • Thessaloníki, Greece
    • Theagenio Cancer Hospital
  • Volos, Greece
    • General Hospital of Volos "Achillopouleio"
  • Véroia, Greece
    • General Hospital of Veroia
• Ireland
  • Cork, Ireland
    • Cork University Hospital Group
  • Dublin, Ireland
    • St Vincents University Hospital
  • Dublin, Ireland
    • Tallaght Hospital
• Israel
  • Jerusalem, Israel
    • Shaare Zedek Medical Center
  • Nahariya, Israel
    • Galilee Medical Center
  • Petah tikva, Israel
    • Rabin Medical Center Beilinson Hospital
  • Ramat Gan, Israel
    • Sheba Academic Medical Center
  • Tel Aviv, Israel
    • Tel Aviv Sourasky Medical Center
• Netherlands
  • Dordrecht, Netherlands
    • Albert Schweitzer Hospital
  • Maastricht, Netherlands
    • Maastricht UMC+
  • Rotterdam, Netherlands
    • Maasstad Ziekenhuis
  • Utrecht, Netherlands
    • University Medical Center Utrecht
• North Macedonia
  • Skopje, North Macedonia
    • University Clinic for Gyn & Ob / Clinical Center Mother Teresa
  • Skopje, North Macedonia
    • University Clinic for Traumatology, Orthopedics, Anesthesia, Reanimation, and Intensive Care Medicine
• Poland
  • Kraków, Poland
    • Jagiellonian University Medical College
• Portugal
  • Coimbra, Portugal
    • Centro Hospitalar e Universitario de Coimbra
  • Lisboa, Portugal
    • Centro Hospitalar Lisboa Norte - Hospital Santa Maria
  • Penafiel, Portugal
    • Centro Hospitalar Tâmega e Sousa
• Romania
  • Bucharest, Romania
    • Clinical Emergency Hospital of Bucharest
  • Bucharest, Romania
    • Fundeni Clinical Institute
  • Bucharest, Romania
    • University Emergency Central Military Hospital
  • Bucuresti, Romania
    • Emergency Institute for Cardiovascular Diseases "Prof CC Iliescu"
  • Cluj-Napoca, Romania
    • Emergency county hospital Cluj
• Russian Federation
  • Chelyabinsk, Russian Federation
    • GBUZ Chelyabinsk regional clinical center of oncology and nuclear medicine
  • Moscow, Russian Federation
    • 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
    • NN Blokhin National Medical Cancer Research Center
  • Moscow, Russian Federation
    • P.A. Herzen Moscow Cancer Research Institute
• Serbia
  • Belgrade, Serbia
    • Clinical Centre of Serbia
  • Belgrade, Serbia
    • 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
    • Emergency Center, Clinical Center of Serbia
  • Belgrade, Serbia
    • Urology Hospital, Clinical center of Serbia
  • Niš, Serbia
    • Clinical Center Nis
  • Sremska Mitrovica, Serbia
    • General Hospital Sremska Mitrovica
• Spain
  • Alcorcón, Spain
    • Hospital Universitario Fundacion Alcorcon
  • Barcelona, Spain
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain
    • Hospital Universitari Sagrat Cor
  • Barcelona, Spain
    • Consorci Sanitari Integral
  • Barcelona, Spain
    • CSI Hospital General de l'Hospitalet
  • Ciudad Real, Spain
    • Universitary General Hospital of Ciudad Real
  • Las Palmas De Gran Canaria, Spain
    • Hospital Universitario de Gran Canaria Doctor Negrin
  • León, Spain
    • Hospital of León
  • Logroño, Spain
    • San Pedro Hospital
  • Madrid, Spain
    • Hospital Ramon y Cajal
  • Madrid, Spain
    • Hospital General Gregorio Marañón
  • Madrid, Spain
    • Hospital Universitario La Princesa
  • Madrid, Spain
    • Hospital Universitario Infanta Leonor
  • Sant Joan Despí, Spain
    • Hospital de Sant Joan Despí Moises Broggi - Consorci Sanitari Integral
  • Valencia, Spain
    • Hospital Clínico Universitario
  • Vitoria, Spain
    • Hospital Universitario Araba
  • Zaragoza, Spain
    • Hospital Universitario Miguel Servet
• Switzerland
  • Basel, Switzerland
    • University Hospital Basel
  • Liestal, Switzerland
    • Kantonsspital Baselland Liestal
  • Lucerne, Switzerland
    • Hirslanden Clinic St. Anna Lucern
  • Schlieren, Switzerland
    • Spital Limmattal
  • Solothurn, Switzerland
    • Bürgerspital Solothurn
• Turkey
  • Ankara, Turkey
    • Ankara University Cebeci Hospital
  • Ankara, Turkey
    • Ankara University Faculty of Medicine-Ibni Sina Hospital
  • Ankara, Turkey
    • Ufuk University Dr. Ridvan Ege Hospital
  • Ankara, Turkey
    • University of Health Sciences Diskapi Yildirim Beyazit Education and Training Hospital
  • Balıkesir, Turkey
    • Balikesir Ataturk City Hospital
  • Derince, Turkey
    • Kocaeli Derince Training and Research Hospital
  • Erzurum, Turkey
    • TR Ministry of Health Erzurum Palandoken State Hospital
  • Istanbul, Turkey
    • Istanbul University, Istanbul Faculty of Medicine
  • Istanbul, Turkey
    • Marmara University Pendik Training and Research Hospital
  • Istanbul, Turkey
    • Baltalimani Metin Sabanci Bone and Joint Diseases Education and Research Hospital
  • Istanbul, Turkey
    • Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
  • Konya, Turkey
    • Baskent University Konya Research Center
  • Konya, Turkey
    • Konya Education and Research Hospital
  • Rize, Turkey
    • RTE university school of medicine
  • Sakarya, Turkey
    • Sakarya University School od Medicine
  • Tunceli, Turkey
    • Republic of Turkey Ministry of Health Tunceli State Hospital
  • İzmir, Turkey
    • Dokuz Eylul University Faculty of Medicine
  • İzmir, Turkey
    • Saglik Bilimleri University Tepecik Education and Research Hospital
• Ukraine
  • Zaporizhzhya, Ukraine
    • Zaporizhzhia State Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Each kind of surgical or non-surgical intervention with anesthesia applied by an anesthetist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From intervention until day 30.
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	From intervention up to 30-days after intervention
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	From intervention up to 30-days after intervention
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.	From intervention up to 30-days after intervention
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.	From intervention up to 30-days after intervention
Unplanned intensive care unit admission	Number of patients	From intervention until hospital discharge or maximum 30-days after intervention
Unplanned intubation after intervention	Number of patients	From intervention until hospital discharge or maximum 30-days after intervention
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.	From intervention until hospital discharge or maximum 30-days after intervention
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	From intervention until hospital discharge or maximum 30-days after intervention
Patient's functional status of independency	Scale assessed by interview of the patient according to the NSQIP (Independent, partially dependent, totally dependent).	On day 30 after intervention
Brief screen for cognitive impairment	Number of correct recall of three words (Brief Screen for Cognitive Impairment test)	On day 30 after intervention
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	On day 30 after intervention
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	Intra-interventional
Number of patients with premedication	Number of patients with premedication given before intervention.	Intra-interventional
Type of anesthesia technique	Number of patients with a specific type of anesthesia technique (e.g. spinal, general etc)	Intra-interventional
Type of the main anesthetic	Number of patients with a specific type of anesthesia drugs (e.g. desflurane, isoflurane etc.)	Intra-interventional
Type of the main intra-interventional opioid	Number of patients with a specific type of opioid for anesthesia (e.g. fentanyl etc.)	Intra-interventional
Anesthesia duration	Begin to end of anesthesia for intervention	Intra-interventional
Amount of intra-interventionally transfused blood and blood products	e.g. transfusion of packed red blood cells, fresh frozen plasmas and platelets	Intra-interventional
Number of extubated patients	At the end of intervention	Intra-interventional
Kind of intervention	Surgical procedure category, severity, urgency, wound class	Intra-interventional
Use of WHO safe surgery checklist	Number of patients , where the WHO safe surgery checklist was used	Intra-interventional
Kind of referring facility	Number of patients referred from home,other hospital, rehabilitation, nursing home or other referring facility, respectively.	Pre-interventional at baseline visit
Amount of pre-interventional comorbidities	Number of comorbidities	pre-interventional at baseline visit
Albumin and hematocrit level before intervention	Optional assessment, only if done in the clinical routine	pre-interventional at baseline visit
Number of falls in the last 6 months	Number of falls per patient	pre-interventional at baseline visit
Mini-Cog (for the cognitive status)	Performance of the mini-cog test and analysis of the maximum points in this test	pre-interventional at baseline visit
Pre-interventional timed "Up & Go" test	Seconds to perform the up and go test will be measured	pre-interventional at baseline visit
Comparison of the patients' outcomes across Europe	Comparing the number of adverse outcomes between the hospitals and countries	30 days after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age and gender-effect on the 30 day mortality	Association of patient age/ gender and mortality	30 days after intervention
Effect of pre-interventional morbidities on the 30 day mortality	Association of pre-operative morbidities and mortality	30 days after intervention
Effect of type of surgery or non-surgical intervention on the 30 day mortality	Association of type of surgery or non-surgical intervention and mortality	30 days after intervention
Effect of centre and country on the 30 day mortality	Association of center/ country and mortality	30 days after intervention
In-hospital cardiopulmonary resuscitation	Rate	From intervention until hospital discharge or maximum 30-days after intervention

Collaborators and Investigators

• Sponsor: Mark Coburn
• Investigators: Study Chair: Mark Coburn, MD, Department of Anesthesiology, University Hospital Aachen, Germany

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): January 30, 2019
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Elderly patients, Mortality, morbidity, post-intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 17-070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No