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Prospective Evaluation of a RIsk Score for postoperative pulmonary COmPlications in Europe (PERISCOPE) is a multi-centre, international observational study of a random-sample cohort of patients undergoing a nonobstetric in-hospital surgical procedure under general or regional anaesthesia during a continued 7-day period of recruitment.
Prospective Evaluation of a RIsk Score for postoperative pulmonary COmPlications in Europe (PERISCOPE) is a multi-centre, international observational study of a random-sample cohort of patients undergoing a nonobstetric in-hospital surgical procedure under general or regional anaesthesia during a continued 7-day period of recruitment.
Participating centres throughout Europe will contribute routine clinical data describing all eligible patients who undergo surgery during a continuous week (7-days) at convenience of every department within a period of two months from May 1st to July 1st 2011. A questionnaire of around 50 items will be filled during the pre, intra and postoperative periods. The follow-up will end at discharge. The aim of the PERISCOPE study is to validate a simple score to predict postoperative pulmonary complications(PPCs). This score has recently been published in Anesthesiology and you can access linking to: http://journals.lww.com/anesthesiology/Fulltext/2010/12000/Prediction\_of\_Postoperative\_Pulmonary.20.aspx
TIMEFRAME Participants will be followed for the duration of in-hospital stay, an expected average of maximum 5 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-patient Adult Non-obstetricSurgical | Consecutive patients admitted to participating centres undergoing surgery Non-obstetric in-hospital surgical procedure, elective or emergent, under general anaesthesia (alone or in combination with regional/neuraxial anaesthesia), neuraxial anaesthesia or plexus block (with and without sedation). All eligible patients undergoing surgery within the seven day study period will be recruited wherever possible. |
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| Measure | Description | Time Frame |
|---|---|---|
| The Main Outcome, Defined as a Postoperative Pulmonary Complications (PPC), Will be a Composite of the In-hospital Fatal or Non-fatal Postoperative Events. | Will include:Mild respiratory failure;Severe respiratory failure;acute lung injury(ALI)/Acute respiratory distress syndrome(ARDS);Suspected pulmonary infection;Pulmonary infiltrate;Pleural effusion;Atelectasis;Pneumothorax;Bronchospasm;Aspiration Pneumonitis;Cardiopulmonary edema.Investigators will not modify centre usual patient management. Patients with PPCs will identify by consulting medical records and looking for events fulfilling PPCdefinition. Diagnosis date for every complication will be recorded.Participants will be followed during in-hospital stay up to 5 weeks. | Postoperative in-hospital stay up to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| a) Postoperative Length of Stay | Participants will be followed for the duration of in-hospital stay up to 90 days | Postoperative in-hospital stay up to 90 days |
| b) In-hospital Mortality | Participants will be followed for the duration of in-hospital stay up to 90 days |
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Inclusion Criteria:
Patients undergoing a non-obstetric in-hospital surgical procedure, elective or emergent, under general anaesthesia (alone or in combination with regional/neuraxial anaesthesia), neuraxial anaesthesia or plexus block (with and without sedation).
Exclusion Criteria:
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In-patient adult non-obstetric surgery
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| Name | Affiliation | Role |
|---|---|---|
| Jaume Canet, MD | Hospital Universitari Germans Trias I Pujol, Barcelona, Spain | Study Director |
| Sergi Sabaté, MD, PhD | Fundació Puigvert (IUNA), Barcelona, Spain | Principal Investigator |
| Olivier Langeron, MD, PhD | Groupe Hospitalier Pitie-Salpetriere | Principal Investigator |
| Marcelo Gama de Abreu, MD,PhD,DEAA | University Hospital Carl Gustav Carus Dresden University of Technology, Dresden, Germany | Principal Investigator |
| LluÃs Gallart, MD | Parc de Salut Mar Anaesthesiology Research Group IMIM, Universitat Autònoma de Barcelona, Barcelona, Spain | Principal Investigator |
| Francisco Javier Belda, MD | Hospital ClÃnico Universitario de Valencia, Valencia, Spain | Principal Investigator |
| Paolo Pelosi, MD, PhD | University of Genoa, Genoa, Italy - San Martino Hospital, Genoa, Italy | Principal Investigator |
| Valentin Mazo, MD | Hospital Universitari Germans Trias I Pujol, Barcelona, Spain | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital centre "Mother Theresa" Anesthesia & critical Care | Tirana | Albania | ||||
| Cliniques Universitaires Saint Luc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21544025 | Background | Canet J, Hardman J, Sabate S, Langeron O, Abreu MG, Gallart L, Belda J, Markstaller K, Pelosi P, Mazo V. PERISCOPE study: predicting post-operative pulmonary complications in Europe. Eur J Anaesthesiol. 2011 Jun;28(6):459-61. doi: 10.1097/EJA.0b013e328344be2d. No abstract available. | |
| 21045639 | Background | Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a. |
| Label | URL |
|---|---|
| The aim of the PERISCOPE study is to validate a simple score to predict postoperative pulmonary complications. This score has recently been published in Anesthesiology and you can access via this link | View source |
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1 week chosen by each centre First Sub First Visit 4-Apr-11 Last data entered 25 Oct 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | In-patient Adult Non-obstetricSurgical | Consecutive patients admitted to participating centres undergoing surgery Non-obstetric in-hospital surgical procedure, elective or emergent, under general anaesthesia (alone or in combination with regional/neuraxial anaesthesia), neuraxial anaesthesia or plexus block (with and without sedation). All eligible patients undergoing surgery within the seven day study period will be recruited wherever possible. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Postoperative in-hospital stay up to 90 days |
| Andreas Hoeft, MD |
| University Hospital, Bonn |
| Principal Investigator |
| Brussels |
| 1200 |
| Belgium |
| General Hospital "Prim.dr Abdulah Nakas" Departement of Anaesthesia and intensive care | Sarajevo | Bosnia and Herzegovina |
| Heart Center | Sarajevo | Bosnia and Herzegovina |
| University Hospital Rijeka Anaesthesiology and Intensive care | Rijeka | Croatia |
| Faculty Hospital Brno, department of Anaesthesiology and Intensive Care Medicine | Brno | Czechia |
| Masaryks hospital Usti nad labem, Dept. of Anesthesia and intensive medicine | Ústà nad Labem | Czechia |
| Tartu University Hospital Clinic of Anaesthesiology and Intensive Care | Tartu | Estonia |
| Hôpital Pitié-Salpêtrière, Anesthesiology and Critical Care | Paris | France |
| University Hospital Bonn, Anesthesiology | Bonn | Germany |
| Klinikum Darmstadt GmbH Anesthesiology, Intensive Care and pain medicin | Darmstadt | Germany |
| University Hospital Carl Gustav Carus, Dresden University of Technonology, Department of Anesthesiology and Intensive Care Therapy | Dresden | Germany |
| Universitätsmedizin Mainz, Departement of Anesthesiology | Mainz | Germany |
| MISEK Kft., Anaesthesiology and Intensive Care Unit | Miskolc | Hungary |
| S.Orsola-Malpighi | Bologna | Italy |
| Azienda Ospedaliera S. Croce e Carle, Anesthesia | Cuneo | Italy |
| Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate | Genoa | Italy |
| European Institute of Oncology,Anaesthesia and Intensive Care | Milan | Italy |
| University of Milano, Ospedale San Paolo Dpt Of Anaesthesia and Intensive Care | Milan | Italy |
| Azienda Ospedaliera Padova, Anesthesia and Intensive Care Clinic, Department of Pharmacology and Anesthesiology | Padova | Italy |
| Azienda USL n. 5 di Pisa Ospedale F. Lotti Anestesia e Rianimazione | Pontedera | Italy |
| University Of Insubria | Varese | Italy |
| P Stradins Clinical University hospital, Departement of Anesthesiology | Riga | Latvia |
| Hospital of Lithuanian University of Health Sciences, Clinic of Anaesthesiology | Kaunas | Lithuania |
| Vilnius University Hospital Santariskiu Clinics, Center of Anesthesiology, Intensive Care and Pain Treatment | Vilnius | Lithuania |
| ZithaKlinik, Anaesthesiology and Intensive Care | Luxembourg | Luxembourg |
| 10 Wojskowy Szpital Kliniczny z PoliklinikÄ… w Bydgoszczy, Anaesthesiology and Intensive Care | Bydgoszcz | Poland |
| Hospitais da Universidade de Coimbra, EPE. Departement of Anesthesiology | Coimbra | Portugal |
| Centro Hospitalar de Lisboa Ocidental, Serviço de Anestesia | Lisbon | Portugal |
| Hospital Fernando Fonseca,Anesthesiology | Lisbon | Portugal |
| Instituto Português de Oncologia, Departement of Anesthesiology | Porto | Portugal |
| Emergency Institute of Cardiovascular Diseases Prof Dr C. C. Iliescu, Cardiac Anesthesia and Intensive Care | Bucharest | Romania |
| Emergency Clinical Hospital of Constanta, Department of Anaesthesiology and Intensive Care | Constanța | Romania |
| Emergency County Hospital Clinic of Anesthesia and Intensive Care, Intensive Care and Anesthesiology | Târgu Mureş | Romania |
| Krasnoyarsk State Medical University,Anesthesiology and Intensive Care | Krasnoyarsk | Russia |
| Hospital General Universitario Alicante, Anaesthesiology | Alicante | Spain |
| Hospital Universitari Germans Trias i Pujol, Anaesthesiology | Badalona | Spain |
| Corporació Sanità ria Parc TaulÃ, Anaesthesiology | Barcelona | Spain |
| Fundació Puigvert Anaesthesiology | Barcelona | Spain |
| Hospital Clinic, Anaesthesiology | Barcelona | Spain |
| Hospital Sant Pau, Anaesthesiology | Barcelona | Spain |
| Parc de Salut Mar, Anesthesiology | Barcelona | Spain |
| Vall d'Hebron University Hospital, Anaesthesiology | Barcelona | Spain |
| Hospital General de La Palma, AnestesiologÃa y Reanimación | Breña Alta | Spain |
| Hospital de Denia,Anesthesia and Intensive Care | Denia | Spain |
| Hospital San Jorge, Anaesthesiology | Huesca | Spain |
| Hospital Arnau de Vilanova Departement of Anesthesiology | Lleida | Spain |
| Hospital Santa Maria, Departement of Anesthesiology | Lleida | Spain |
| Hospital 12 Octubre, Anaesthesiology | Madrid | Spain |
| Hospital del Tajo Anaesthesia and Reanimation | Madrid | Spain |
| Hospital Universitario de La Princesa, Anesthesiology | Madrid | Spain |
| Hospital Universitario de Móstoles, anestesiologÃa y Reanimación | Madrid | Spain |
| Fundacio Althaia, Anaesthesiology | Manresa | Spain |
| Hospital Son Llatzer, Anaesthesiology | Palma de Mallorca | Spain |
| Clinica Universidad de Navarra, Anaesthesia | Pamplona | Spain |
| Hospital Universitario Marques De Valdecilla | Santander | Spain |
| Virgen del Rocio General Universitary Hospital;Anaesthesiology | Seville | Spain |
| Consorcio Hospital General Universitario, Anesthesiology, Critical Care and Pain Relief Unit | Valencia | Spain |
| Hospital ClÃnic Universitari de València, AnestesiologÃa y Reanimación | Valencia | Spain |
| Hospital Universitario Rio Hortgea, Anaesthesia and Surgical Critical Care | Valladolid | Spain |
| Ospedale Regionale di Lugano, Anestesia | Lugano | Switzerland |
| Medical Faculty of Istanbul, Istanbul University, Anaesthesiology | Istanbul | Turkey (Türkiye) |
| St.Katherine Hospital of Cardiology Anesthesiology & Pain Treatment | Odesa | Ukraine |
| 26020123 | Result | Canet J, Sabate S, Mazo V, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P; PERISCOPE group. Development and validation of a score to predict postoperative respiratory failure in a multicentre European cohort: A prospective, observational study. Eur J Anaesthesiol. 2015 Jul;32(7):458-70. doi: 10.1097/EJA.0000000000000223. |
| 24901240 | Result | Mazo V, Sabate S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000000334. |
| 30431500 | Derived | Russotto V, Sabate S, Canet J; PERISCOPE group; of the European Society of Anaesthesiology (ESA) Clinical Trial Network. Development of a prediction model for postoperative pneumonia: A multicentre prospective observational study. Eur J Anaesthesiol. 2019 Feb;36(2):93-104. doi: 10.1097/EJA.0000000000000921. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | In-patient Adult Non-obstetricSurgical | Consecutive patients admitted to participating centres undergoing surgery Non-obstetric in-hospital surgical procedure, elective or emergent, under general anaesthesia (alone or in combination with regional/neuraxial anaesthesia), neuraxial anaesthesia or plexus block (with and without sedation). All eligible patients undergoing surgery within the seven day study period will be recruited wherever possible. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Age, Customized | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
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| Smoking status | Number | participants |
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| Chronic obstructive pulmonary disease (COPD) | Number | participants |
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| Functional Status | Number | participants |
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| Hypertension | Number | participants |
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| Heart Failure | Number | participants |
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| Coronary artery disease | Number | participants |
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| Cerebrovascular disease | Number | participants |
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| Liver disease | Number | participants |
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| Chronic kidney disease | Number | participants |
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| Respiratory Infection in the last month | Number | participants |
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| Preoperative SpO2 (Peripheral capillary oxygen saturation) | Median | Inter-Quartile Range | Percentage |
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| Anemia (<10g/dl) | Number | participants |
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| Geografical Location of Centres | Number | participants |
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| ASA physical status | a system for assessing the fitness of patients before surgery.
| Number | participants |
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| Anaesthesia | Number | participants |
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| Emergency Surgery | Number | participants |
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| Surgical specialty | Number | participants |
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| Surgical Incision | Number | participants |
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| Duration of Surgery (h) median | Median | Inter-Quartile Range | hours |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Main Outcome, Defined as a Postoperative Pulmonary Complications (PPC), Will be a Composite of the In-hospital Fatal or Non-fatal Postoperative Events. | Will include:Mild respiratory failure;Severe respiratory failure;acute lung injury(ALI)/Acute respiratory distress syndrome(ARDS);Suspected pulmonary infection;Pulmonary infiltrate;Pleural effusion;Atelectasis;Pneumothorax;Bronchospasm;Aspiration Pneumonitis;Cardiopulmonary edema.Investigators will not modify centre usual patient management. Patients with PPCs will identify by consulting medical records and looking for events fulfilling PPCdefinition. Diagnosis date for every complication will be recorded.Participants will be followed during in-hospital stay up to 5 weeks. | PPC incidence, Percentage in Patients valid for external validation study | Posted | Number | 95% Confidence Interval | Percentage of Participants | Postoperative in-hospital stay up to 5 weeks |
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| Secondary | a) Postoperative Length of Stay | Participants will be followed for the duration of in-hospital stay up to 90 days | Posted | Median | Inter-Quartile Range | days | Postoperative in-hospital stay up to 90 days |
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| Secondary | b) In-hospital Mortality | Participants will be followed for the duration of in-hospital stay up to 90 days | Posted | Number | percentage of Participants | Postoperative in-hospital stay up to 90 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational Study Section Not Applicable | observational study section not applicable | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brigitte Leva, Research Team Leader | European Society of anaesthesiology | +3222109414 | research@esahq.org |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D055371 | Acute Lung Injury |
| D012128 | Respiratory Distress Syndrome |
| D010996 | Pleural Effusion |
| D001261 | Pulmonary Atelectasis |
| D011030 | Pneumothorax |
| D001986 | Bronchial Spasm |
| D011015 | Pneumonia, Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D010995 | Pleural Diseases |
| D001982 | Bronchial Diseases |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Title | Measurements |
|---|---|
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| Current Smoker |
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| Eastern Europe Centres |
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| 3 |
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| 4 |
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| Urology |
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| Gynecology |
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| Ear, nose, throat |
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| Vascular |
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| Breast |
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| Cardiac |
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| Thoracic |
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| Neurosurgery |
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| Other |
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| Intrathoracic/cardiac |
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