Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-01-03 @ 6:00 PM
Study NCT ID:
NCT03152734
Status:
COMPLETED
Last Update Posted:
2019-11-20
First Post:
2017-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Periinterventional Outcome Study in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Cyprus', 'Italy', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-19', 'studyFirstSubmitDate': '2017-05-09', 'studyFirstSubmitQcDate': '2017-05-11', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age and gender-effect on the 30 day mortality', 'timeFrame': '30 days after intervention', 'description': 'Association of patient age/ gender and mortality'}, {'measure': 'Effect of pre-interventional morbidities on the 30 day mortality', 'timeFrame': '30 days after intervention', 'description': 'Association of pre-operative morbidities and mortality'}, {'measure': 'Effect of type of surgery or non-surgical intervention on the 30 day mortality', 'timeFrame': '30 days after intervention', 'description': 'Association of type of surgery or non-surgical intervention and mortality'}, {'measure': 'Effect of centre and country on the 30 day mortality', 'timeFrame': '30 days after intervention', 'description': 'Association of center/ country and mortality'}, {'measure': 'In-hospital cardiopulmonary resuscitation', 'timeFrame': 'From intervention until hospital discharge or maximum 30-days after intervention', 'description': 'Rate'}], 'primaryOutcomes': [{'measure': 'Peri-interventional (surgical and non-surgical interventional) all-cause mortality rate on day 30', 'timeFrame': 'From intervention until day 30.', 'description': 'Number of patients with death from any cause'}], 'secondaryOutcomes': [{'measure': 'In-hospital outcome according to the ACS National Surgical Quality Improvement Program® (ACS NSQIP®)', 'timeFrame': 'From intervention until day 30.', 'description': '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'}, {'measure': 'Analysis of the new-onset of serious cardiac complications', 'timeFrame': 'From intervention up to 30-days after intervention', 'description': 'Number of patients with serious cardiac complication\n\nCardiac complication is defined according to the American Heart Association'}, {'measure': 'Analysis of the new-onset of serious pulmonary complications', 'timeFrame': 'From intervention up to 30-days after intervention', 'description': 'Number of patients with\n\n* Pneumonia: Clinical or radiological diagnosis. or\n* Pulmonary embolism: Radiological diagnosis. Signs of pneumonia or pulmonary embolism in the autopsy'}, {'measure': 'Analysis of the new-onset of acute stroke', 'timeFrame': 'From intervention up to 30-days after intervention', 'description': '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.'}, {'measure': 'Analysis of the new-onset of acute kidney injury', 'timeFrame': 'From intervention up to 30-days after intervention', 'description': 'Number of patients with new-onset of acute kidney injury, defined according to the AKIN classification as AKI stage ≥2.\n\nThis 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.'}, {'measure': 'Unplanned intensive care unit admission', 'timeFrame': 'From intervention until hospital discharge or maximum 30-days after intervention', 'description': 'Number of patients'}, {'measure': 'Unplanned intubation after intervention', 'timeFrame': 'From intervention until hospital discharge or maximum 30-days after intervention', 'description': 'Number of patients'}, {'measure': 'Hospital discharge destination', 'timeFrame': 'From intervention until hospital discharge or maximum 30-days after intervention', 'description': '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.'}, {'measure': 'Perioperative admission to a unit with a geriatric care model', 'timeFrame': 'From intervention until hospital discharge or maximum 30-days after intervention', 'description': 'Number of patients, which are post-interventionally admitted to e.g. geriatric units, geriatric co-management models, geriatric liaison services'}, {'measure': "Patient's functional status of independency", 'timeFrame': 'On day 30 after intervention', 'description': 'Scale assessed by interview of the patient according to the NSQIP (Independent, partially dependent, totally dependent).'}, {'measure': 'Brief screen for cognitive impairment', 'timeFrame': 'On day 30 after intervention', 'description': 'Number of correct recall of three words (Brief Screen for Cognitive Impairment test)'}, {'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', 'description': 'Comparing the number of via preoperative NSQIP risk calculator and POSPOM predicted outcomes with the number of postoperative outcomes of the patient'}, {'measure': 'Number of used intra-interventional monitoring for elderly patients in the clinical routine', 'timeFrame': 'Intra-interventional', 'description': 'Number of patients, where a specific monitoring device was intra-interventionally used'}, {'measure': 'Number of patients with premedication', 'timeFrame': 'Intra-interventional', 'description': 'Number of patients with premedication given before intervention.'}, {'measure': 'Type of anesthesia technique', 'timeFrame': 'Intra-interventional', 'description': 'Number of patients with a specific type of anesthesia technique (e.g. spinal, general etc)'}, {'measure': 'Type of the main anesthetic', 'timeFrame': 'Intra-interventional', 'description': 'Number of patients with a specific type of anesthesia drugs (e.g. desflurane, isoflurane etc.)'}, {'measure': 'Type of the main intra-interventional opioid', 'timeFrame': 'Intra-interventional', 'description': 'Number of patients with a specific type of opioid for anesthesia (e.g. fentanyl etc.)'}, {'measure': 'Anesthesia duration', 'timeFrame': 'Intra-interventional', 'description': 'Begin to end of anesthesia for intervention'}, {'measure': 'Amount of intra-interventionally transfused blood and blood products', 'timeFrame': 'Intra-interventional', 'description': 'e.g. transfusion of packed red blood cells, fresh frozen plasmas and platelets'}, {'measure': 'Number of extubated patients', 'timeFrame': 'Intra-interventional', 'description': 'At the end of intervention'}, {'measure': 'Kind of intervention', 'timeFrame': 'Intra-interventional', 'description': 'Surgical procedure category, severity, urgency, wound class'}, {'measure': 'Use of WHO safe surgery checklist', 'timeFrame': 'Intra-interventional', 'description': 'Number of patients , where the WHO safe surgery checklist was used'}, {'measure': 'Kind of referring facility', 'timeFrame': 'Pre-interventional at baseline visit', 'description': 'Number of patients referred from home,other hospital, rehabilitation, nursing home or other referring facility, respectively.'}, {'measure': 'Amount of pre-interventional comorbidities', 'timeFrame': 'pre-interventional at baseline visit', 'description': 'Number of comorbidities'}, {'measure': 'Albumin and hematocrit level before intervention', 'timeFrame': 'pre-interventional at baseline visit', 'description': 'Optional assessment, only if done in the clinical routine'}, {'measure': 'Number of falls in the last 6 months', 'timeFrame': 'pre-interventional at baseline visit', 'description': 'Number of falls per patient'}, {'measure': 'Mini-Cog (for the cognitive status)', 'timeFrame': 'pre-interventional at baseline visit', 'description': 'Performance of the mini-cog test and analysis of the maximum points in this test'}, {'measure': 'Pre-interventional timed "Up & Go" test', 'timeFrame': 'pre-interventional at baseline visit', 'description': 'Seconds to perform the up and go test will be measured'}, {'measure': "Comparison of the patients' outcomes across Europe", 'timeFrame': '30 days after intervention', 'description': 'Comparing the number of adverse outcomes between the hospitals and countries'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elderly patients, Mortality, morbidity, post-intervention'], 'conditions': ['Mortality', 'Complication, Postoperative']}, 'referencesModule': {'references': [{'pmid': '39916969', 'type': 'DERIVED', 'citation': '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': '34817420', 'type': 'DERIVED', '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.'}, {'pmid': '34799496', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be selected from secondary and tertiary hospitals in several countries in Europe.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 80 years\n* Written informed consent according to the national law requirements\n* 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\n* Elective and emergency procedures\n* In-patient and out-patient procedures\n\nExclusion Criteria:\n\n* People who are institutionalized by court or administrative order\n* Patients with re-intervention within the 4 week period, who were already enrolled in this study'}, 'identificationModule': {'nctId': 'NCT03152734', 'acronym': 'POSE', 'briefTitle': 'Periinterventional Outcome Study in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Periinterventional Outcome Study in the Elderly (POSE): European, Multi-centre, Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': '17-070'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elderly patient', 'description': 'Elderly patient undergoing surgical and non-surgical intervention with the use of anesthesia provided by an anesthetist', 'interventionNames': ['Procedure: Surgical or non-surgical intervention']}], 'interventions': [{'name': 'Surgical or non-surgical intervention', 'type': 'PROCEDURE', 'description': 'Each kind of surgical or non-surgical intervention with anesthesia applied by an anesthetist', 'armGroupLabels': ['Elderly patient']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Salzburg', 'country': 'Austria', 'facility': 'University Hospital Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'ZNA Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'city': 'Genk', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'AZ Groeninge', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Turnhout', 'country': 'Belgium', 'facility': 'AZ Turnhout', 'geoPoint': {'lat': 51.32254, 'lon': 4.94471}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus Universityhospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet, Neuroscience Centre', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Nordsjællands Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'city': 'Horsens', 'country': 'Denmark', 'facility': 'Hospital Unit Horsens', 'geoPoint': {'lat': 55.86066, 'lon': 9.85034}}, {'city': 'Vejle', 'country': 'Denmark', 'facility': 'Hospitaln Lillebælt', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Bourg-en-Bresse', 'country': 'France', 'facility': 'Centre Hospitalier Fleyriat', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'city': 'Bourgoin', 'country': 'France', 'facility': 'Centre hospitalier Pierre Oudot', 'geoPoint': {'lat': 45.59889, 'lon': 5.27236}}, {'city': 'Brest', 'country': 'France', 'facility': 'HIA Clermont Tonnerre', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Clamart', 'country': 'France', 'facility': "Hopital d'Instruction des Armées Percy", 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'city': 'Le Mans', 'country': 'France', 'facility': 'CH Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Lille', 'country': 'France', 'facility': 'Huriez Hospital, University Hospital of Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Clinique de la Sauvegarde', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Croix Rousse Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Lyon Sud', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Neurologic Hospital-Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'AP-HM Hôpital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Martigues', 'country': 'France', 'facility': 'CH Martigues', 'geoPoint': {'lat': 43.40735, 'lon': 5.05526}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Clinique Saint Jean', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'facility': 'AP-HP, Hopital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Cochin University Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital de la Pitié-Salpe tri ere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Quincy-sous-Sénart', 'country': 'France', 'facility': 'Hopital Prive Claude Galien', 'geoPoint': {'lat': 48.67294, 'lon': 2.53419}}, {'city': 'Reims', 'country': 'France', 'facility': 'University Hospital of Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Saint-Coulomb', 'country': 'France', 'facility': 'Clinique Trenel', 'geoPoint': {'lat': 48.67548, 'lon': -1.91119}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Hôpital Nord', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Clinique Mutualiste Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Saint-Herblain', 'country': 'France', 'facility': "Polyclinique de l'atlantique", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'city': 'Sélestat', 'country': 'France', 'facility': 'Groupe Hospitalier Selestat-Obernai', 'geoPoint': {'lat': 48.26195, 'lon': 7.4489}}, {'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'city': 'Tarbes', 'country': 'France', 'facility': 'Centre Hospitalier de Bigorre', 'geoPoint': {'lat': 43.23407, 'lon': 0.07139}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy Cancer Center', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Batumi', 'country': 'Georgia', 'facility': 'Health centre "Medina"', 'geoPoint': {'lat': 41.64077, 'lon': 41.6306}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': '5th General Hospital "Open Heart"', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Acad. 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