Clinical trial NCT03152734: Periinterventional Outcome Study in the Elderly
Official title: Periinterventional Outcome Study in the Elderly (POSE): European, Multi-centre, Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mortality
Complication, Postoperative
Keywords: Elderly patients, Mortality, morbidity, post-intervention
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 9500
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be selected from secondary and tertiary hospitals in several countries in Europe.

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.

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

Primary outcomes:
measure: Peri-interventional (surgical and non-surgical interventional) all-cause mortality rate on day 30
timeFrame: From intervention until day 30.
Secondary outcomes:
measure: In-hospital outcome according to the ACS National Surgical Quality Improvement Program® (ACS NSQIP®)
timeFrame: From intervention until day 30.
measure: Analysis of the new-onset of serious cardiac complications
timeFrame: From intervention up to 30-days after intervention
measure: Analysis of the new-onset of serious pulmonary complications
timeFrame: From intervention up to 30-days after intervention
measure: Analysis of the new-onset of acute stroke
timeFrame: From intervention up to 30-days after intervention
measure: Analysis of the new-onset of acute kidney injury
timeFrame: From intervention up to 30-days after intervention
measure: Unplanned intensive care unit admission
timeFrame: From intervention until hospital discharge or maximum 30-days after intervention
measure: Unplanned intubation after intervention
timeFrame: From intervention until hospital discharge or maximum 30-days after intervention
measure: Hospital discharge destination
timeFrame: From intervention until hospital discharge or maximum 30-days after intervention
measure: Perioperative admission to a unit with a geriatric care model
timeFrame: From intervention until hospital discharge or maximum 30-days after intervention
measure: Patient's functional status of independency
timeFrame: On day 30 after intervention
measure: Brief screen for cognitive impairment
timeFrame: On day 30 after intervention
measure: Comparing the postoperative in-hospital and 30-day outcome with preoperatively via NSQIP risk calculator and POSPOM predicted outcome for surgeries
timeFrame: On day 30 after intervention
measure: Number of used intra-interventional monitoring for elderly patients in the clinical routine
timeFrame: Intra-interventional
measure: Number of patients with premedication
timeFrame: Intra-interventional
measure: Type of anesthesia technique
timeFrame: Intra-interventional
measure: Type of the main anesthetic
timeFrame: Intra-interventional
measure: Type of the main intra-interventional opioid
timeFrame: Intra-interventional
measure: Anesthesia duration
timeFrame: Intra-interventional
measure: Amount of intra-interventionally transfused blood and blood products
timeFrame: Intra-interventional
measure: Number of extubated patients
timeFrame: Intra-interventional
measure: Kind of intervention
timeFrame: Intra-interventional
measure: Use of WHO safe surgery checklist
timeFrame: Intra-interventional
measure: Kind of referring facility
timeFrame: Pre-interventional at baseline visit
measure: Amount of pre-interventional comorbidities
timeFrame: pre-interventional at baseline visit
measure: Albumin and hematocrit level before intervention
timeFrame: pre-interventional at baseline visit
measure: Number of falls in the last 6 months
timeFrame: pre-interventional at baseline visit
measure: Mini-Cog (for the cognitive status)
timeFrame: pre-interventional at baseline visit
measure: Pre-interventional timed "Up & Go" test
timeFrame: pre-interventional at baseline visit
measure: Comparison of the patients' outcomes across Europe
timeFrame: 30 days after intervention
Other outcomes:
measure: Age and gender-effect on the 30 day mortality
timeFrame: 30 days after intervention
measure: Effect of pre-interventional morbidities on the 30 day mortality
timeFrame: 30 days after intervention
measure: Effect of type of surgery or non-surgical intervention on the 30 day mortality
timeFrame: 30 days after intervention
measure: Effect of centre and country on the 30 day mortality
timeFrame: 30 days after intervention
measure: In-hospital cardiopulmonary resuscitation
timeFrame: From intervention until hospital discharge or maximum 30-days after intervention
Locations:
city: Salzburg
country: Austria
facility: University Hospital Salzburg
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Gent
country: Belgium
facility: Ghent University Hospital
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Turnhout
country: Belgium
facility: AZ Turnhout
city: Aarhus
country: Denmark
facility: Aarhus Universityhospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Neuroscience Centre
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
city: Horsens
country: Denmark
facility: Hospital Unit Horsens
city: Vejle
country: Denmark
facility: Hospitaln Lillebælt
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Angers
country: France
facility: CHU Angers
city: Bourg-en-Bresse
country: France
facility: Centre Hospitalier Fleyriat
city: Bourgoin-Jallieu
country: France
facility: Centre hospitalier Pierre Oudot
city: Brest
country: France
facility: HIA Clermont Tonnerre
city: Clamart
country: France
facility: Hopital d'Instruction des Armées Percy
city: Le Mans
country: France
facility: CH Le Mans
city: Lille
country: France
facility: Huriez Hospital, University Hospital of Lille
city: Lyon
country: France
facility: Clinique de la Sauvegarde
city: Lyon
country: France
facility: Croix Rousse Hospital
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Lyon
country: France
facility: Hôpital Lyon Sud
city: Lyon
country: France
facility: Neurologic Hospital-Hospices Civils de Lyon
city: Marseille
country: France
facility: AP-HM Hôpital Nord
city: Martigues
country: France
facility: CH Martigues
city: Montpellier
country: France
facility: Clinique Saint Jean
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: AP-HP, Hopital Saint-Louis
city: Paris
country: France
facility: Cochin University Hospital
city: Paris
country: France
facility: Hopital de la Pitié-Salpe tri ere
city: Paris
country: France
facility: Hopital Saint Antoine
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Quincy-sous-Sénart
country: France
facility: Hopital Prive Claude Galien
city: Reims
country: France
facility: University Hospital of Reims
city: Saint-Herblain
country: France
facility: Polyclinique de l'atlantique
city: Saint-Étienne
country: France
facility: CHU Hôpital Nord
city: Saint-Étienne
country: France
facility: Clinique Mutualiste Saint Etienne
city: St Coulomb
country: France
facility: Clinique Trenel
city: Suresnes
country: France
facility: Hopital Foch
city: Sélestat
country: France
facility: Groupe Hospitalier Selestat-Obernai
city: Tarbes
country: France
facility: Centre Hospitalier de Bigorre
city: Toulouse
country: France
facility: CHU Toulouse
city: Villejuif
country: France
facility: Gustave Roussy Cancer Center
city: Batumi
country: Georgia
facility: Health centre "Medina"
city: Tbilisi
country: Georgia
facility: 5th General Hospital "Open Heart"
city: Tbilisi
country: Georgia
facility: Acad. N. Kipshidze Central University Clinic
city: Tbilisi
country: Georgia
facility: EVEX Traumatology Hospital
city: Tbilisi
country: Georgia
facility: Medical Corporation Evex, Tbilisi Referral Hospital
city: Tbilisi
country: Georgia
facility: Mediclubgeorgia
city: Tbilisi
country: Georgia
facility: New Hospital
city: Tbilisi
country: Georgia
facility: Oftalmij
city: Zugdidi
country: Georgia
facility: Medical Corporation Evex - Zugdidi Referral Hospital
city: Aachen
country: Germany
facility: Department of Anesthesiology, University Hospital Aachen
state: NRW
city: Bochum
country: Germany
facility: St. Josef- Hospital
city: Bochum
country: Germany
facility: University Hospital Knappschaftskrankenhaus Bochum
city: Bonn
country: Germany
facility: University of Bonn
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus Dresden
city: Duesseldorf
country: Germany
facility: Heinrich-Heine University Duesseldorf
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
city: Hannover
country: Germany
facility: Hannover Medical School
city: Herne
country: Germany
facility: Marien Hospital Herne, UK der Ruhr-Universität Bochum
city: Jena
country: Germany
facility: Jena University Hospital
city: Luebeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Luebeck
city: Marburg
country: Germany
facility: Universitaetsklinikum Marburg
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: Muenchen
country: Germany
facility: Klinikum der Ludwigs-Maximilians-Universität München (LMU)
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar der TU München
city: Münster
country: Germany
facility: St. Franziskus-Hospital Münster
city: Münster
country: Germany
facility: University Hospital Münster
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg AÖR
city: Tuebingen
country: Germany
facility: University Hospital Tübingen
city: Wuppertal
country: Germany
facility: Kliniverbund St. Antonius und St. Josef GmbH
city: Würzburg
country: Germany
facility: University Hospital of Wuerzburg
city: Alexandroupolis
country: Greece
facility: Democritus University of Thrace
city: Athens
country: Greece
facility: Alexandra Hospital
city: Athens
country: Greece
facility: Evangelismos General Hospital
city: Athens
country: Greece
facility: General Hospital of Athens "G. Gennimatas"
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Center
city: Chaïdári
country: Greece
facility: Attikon University Hospital
city: Ioánnina
country: Greece
facility: University Hospital of Ioannina
city: Kavála
country: Greece
facility: General Hospital of Kavala
city: Komotiní
country: Greece
facility: Komotini General Hospital
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Patra
country: Greece
facility: University Hospital of Patras
city: Piraeus
country: Greece
facility: Tzaneio General Hospital of Pireaus
city: Thessaloníki
country: Greece
facility: AHEPA University Hospital
city: Thessaloníki
country: Greece
facility: General Hospital Papanikolaou
city: Thessaloníki
country: Greece
facility: George Papanikolaou
city: Thessaloníki
country: Greece
facility: Hippokrateion General Hospital
city: Thessaloníki
country: Greece
facility: Medical School, Aristotle University of Thessaloniki
city: Thessaloníki
country: Greece
facility: Theagenio Cancer Hospital
city: Volos
country: Greece
facility: General Hospital of Volos "Achillopouleio"
city: Véroia
country: Greece
facility: General Hospital of Veroia
city: Cork
country: Ireland
facility: Cork University Hospital Group
city: Dublin
country: Ireland
facility: St Vincents University Hospital
city: Dublin
country: Ireland
facility: Tallaght Hospital
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Petah tikva
country: Israel
facility: Rabin Medical Center Beilinson Hospital
city: Ramat Gan
country: Israel
facility: Sheba Academic Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Skopje
country: North Macedonia
facility: University Clinic for Gyn & Ob / Clinical Center Mother Teresa
city: Skopje
country: North Macedonia
facility: University Clinic for Traumatology, Orthopedics, Anesthesia, Reanimation, and Intensive Care Medicine
city: Kraków
country: Poland
facility: Jagiellonian University Medical College
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte - Hospital Santa Maria
city: Penafiel
country: Portugal
facility: Centro Hospitalar Tamega e Sousa
city: Bucharest
country: Romania
facility: Clinical Emergency Hospital of Bucharest
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Bucharest
country: Romania
facility: University Emergency Central Military Hospital
city: Bucuresti
country: Romania
facility: Emergency Institute for Cardiovascular Diseases "Prof CC Iliescu"
city: Cluj-Napoca
country: Romania
facility: Emergency County Hospital Cluj
city: Chelyabinsk
country: Russian Federation
facility: GBUZ Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
city: Moscow
country: Russian Federation
facility: 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)
city: Moscow
country: Russian Federation
facility: NN Blokhin National Medical Cancer Research Center
city: Moscow
country: Russian Federation
facility: P.A. Herzen Moscow Cancer Research Institute
city: Belgrade
country: Serbia
facility: Cardiovacular Institute Dedinje
city: Belgrade
country: Serbia
facility: CHC Bezaniska Kosa
city: Belgrade
country: Serbia
facility: Clinic for ENT and maxillofacial surgery, Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinic for orthopedics surgery and traumatology Clinical center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia, Cener for anaestesia , Department for digestive surgery
city: Belgrade
country: Serbia
facility: Clinical Centre of Serbia
city: Belgrade
country: Serbia
facility: Emergency Center, Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Urology Hospital, Clinical center of Serbia
city: Niš
country: Serbia
facility: Clinical Center Nis
city: Sremska Mitrovica
country: Serbia
facility: General Hospital Sremska Mitrovica
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
city: Barcelona
country: Spain
facility: Consorci Sanitari Integral
city: Barcelona
country: Spain
facility: CSI Hospital General de l'Hospitalet
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Sagrat Cor
city: Ciudad Real
country: Spain
facility: Universitary General Hospital of Ciudad Real
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrin
city: León
country: Spain
facility: Hospital of Leon
city: Logroño
country: Spain
facility: San Pedro Hospital
city: Madrid
country: Spain
facility: Hospital General Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Sant Joan Despí
country: Spain
facility: Hospital de Sant Joan Despí Moises Broggi - Consorci Sanitari Integral
city: Valencia
country: Spain
facility: Hospital Clinico Universitario
city: Vitoria
country: Spain
facility: Hospital Universitario Araba
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland Liestal
city: Lucerne
country: Switzerland
facility: Hirslanden Clinic St. Anna Lucern
city: Schlieren
country: Switzerland
facility: Spital Limmattal
city: Solothurn
country: Switzerland
facility: Bürgerspital Solothurn
city: Ankara
country: Turkey
facility: Ankara University Cebeci Hospital
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine-Ibni Sina Hospital
city: Ankara
country: Turkey
facility: Ufuk University Dr. Ridvan Ege Hospital
city: Ankara
country: Turkey
facility: University of Health Sciences Diskapi Yildirim Beyazit Education and Training Hospital
city: Balıkesir
country: Turkey
facility: Balikesir Atatürk City Hospital
city: Derince
country: Turkey
facility: Kocaeli Derince Training and Research Hospital
city: Erzurum
country: Turkey
facility: TR Ministry of Health Erzurum Palandoken State Hospital
city: Istanbul
country: Turkey
facility: Baltalimani Metin Sabanci Bone and Joint Diseases Education and Research Hospital
city: Istanbul
country: Turkey
facility: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul University, Istanbul Faculty of Medicine
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
city: İzmir
country: Turkey
facility: Dokuz Eylul University Faculty of Medicine
city: İzmir
country: Turkey
facility: Saglik Bilimleri University Tepecik Education and Research Hospital
city: Konya
country: Turkey
facility: Baskent University Konya Research Center
city: Konya
country: Turkey
facility: Konya Education and Research Hospital
city: Rize
country: Turkey
facility: RTE university school of medicine
city: Sakarya
country: Turkey
facility: Sakarya University School od Medicine
city: Tunceli
country: Turkey
facility: Republic of Turkey Ministry of Health Tunceli State Hospital
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhia State Medical University
Study officials:
affiliation: Department of Anesthesiology, University Hospital Aachen, Germany
name: Mark Coburn, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.