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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01346709
Other study ID # PERISCOPE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2011
Est. completion date September 2011

Study information

Verified date October 2015
Source European Society of Anaesthesiology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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_Pulmon ary.20.aspx TIMEFRAME Participants will be followed for the duration of in-hospital stay, an expected average of maximum 5 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 5450
Est. completion date September 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: 1. age <18 years 2. obstetric procedures or any procedure during pregnancy 3. regional anaesthesia alone, except to neuroaxial and plexus anaesthesia 4. procedures outside the operating room 5. procedures related to a previous postoperative complication 6. transplantation 7. patients with preoperatively intubated trachea 8. outpatient procedures, defined as those requiring less than one day's stay for a patient alive at discharge.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Albania University Hospital centre "Mother Theresa" Anesthesia & critical Care Tirana
Belgium Cliniques Universitaires Saint Luc Brussels
Bosnia and Herzegovina General Hospital "Prim.dr Abdulah Nakas" Departement of Anaesthesia and intensive care Sarajevo
Bosnia and Herzegovina Heart Center Sarajevo
Croatia University Hospital Rijeka Anaesthesiology and Intensive care Rijeka
Czechia Faculty Hospital Brno, department of Anaesthesiology and Intensive Care Medicine Brno
Czechia Masaryks hospital Usti nad labem, Dept. of Anesthesia and intensive medicine Usti Nad Labem
Estonia Tartu University Hospital Clinic of Anaesthesiology and Intensive Care Tartu
France Hôpital Pitié-Salpêtrière, Anesthesiology and Critical Care Paris
Germany 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
Hungary MISEK Kft., Anaesthesiology and Intensive Care Unit Miskolc
Italy 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 Milano
Italy University of Milano, Ospedale San Paolo Dpt Of Anaesthesia and Intensive Care Milano
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
Latvia P Stradins Clinical University hospital, Departement of Anesthesiology Riga
Lithuania 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
Luxembourg ZithaKlinik, Anaesthesiology and Intensive Care Luxembourg
Poland 10 Wojskowy Szpital Kliniczny z Poliklinika w Bydgoszczy, Anaesthesiology and Intensive Care Bydgoszcz
Portugal 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
Romania 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 Constanta
Romania Emergency County Hospital Clinic of Anesthesia and Intensive Care, Intensive Care and Anesthesiology Târgu-Mures
Russian Federation Krasnoyarsk State Medical University,Anesthesiology and Intensive Care Krasnoyarsk
Spain Hospital General Universitario Alicante, Anaesthesiology Alicante
Spain Hospital Universitari Germans Trias i Pujol, Anaesthesiology Badalona
Spain Corporació Sanitària Parc Taulí, 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, Anestesiología 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, anestesiología 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 Clínic Universitari de València, Anestesiología y Reanimación Valencia
Spain Hospital Universitario Rio Hortgea, Anaesthesia and Surgical Critical Care Valladolid
Switzerland Ospedale Regionale di Lugano, Anestesia Lugano
Turkey Medical Faculty of Istanbul, Istanbul University, Anaesthesiology Istanbul
Ukraine St.Katherine Hospital of Cardiology Anesthesiology & Pain Treatment Odessa

Sponsors (1)

Lead Sponsor Collaborator
European Society of Anaesthesiology

Countries where clinical trial is conducted

Albania,  Belgium,  Bosnia and Herzegovina,  Croatia,  Czechia,  Estonia,  France,  Germany,  Hungary,  Italy,  Latvia,  Lithuania,  Luxembourg,  Poland,  Portugal,  Romania,  Russian Federation,  Spain,  Switzerland,  Turkey,  Ukraine, 

References & Publications (4)

Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, Sabaté 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. — View Citation

Canet J, Hardman J, Sabaté 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. — View Citation

Canet J, Sabaté 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 s — View Citation

Mazo V, Sabaté 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.0000000000 — View Citation

Outcome

Type Measure Description Time frame Safety issue
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. Postoperative in-hospital stay up to 5 weeks
Secondary 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
Secondary b) In-hospital Mortality Participants will be followed for the duration of in-hospital stay up to 90 days Postoperative in-hospital stay up to 90 days
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