Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe

Completed

Conditions: Postoperative Respiratory Complications
Surgical Complications From General Anesthesia
Acute Respiratory Failure, Adult
Complication of Surgical Procedure
Pulmonary Failure

Registration Number: NCT01346709

Lead Sponsor: European Society of Anaesthesiology

Brief 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.

Detailed 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_Pulmonary.20.aspx

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 5450

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

age <18 years
obstetric procedures or any procedure during pregnancy
regional anaesthesia alone, except to neuroaxial and plexus anaesthesia
procedures outside the operating room
procedures related to a previous postoperative complication
transplantation
patients with preoperatively intubated trachea
outpatient procedures, defined as those requiring less than one day's stay for a patient alive at discharge.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Main Outcome, Defined as a Postoperative Pulmonary Complications (PPC), Will be a Composite of the In-hospital Fatal or Non-fatal Postoperative Events.	Postoperative in-hospital stay up to 5 weeks	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.

Secondary Outcome Measures

Name	Time	Method
a) Postoperative Length of Stay	Postoperative in-hospital stay up to 90 days	Participants will be followed for the duration of in-hospital stay up to 90 days
b) In-hospital Mortality	Postoperative in-hospital stay up to 90 days	Participants will be followed for the duration of in-hospital stay up to 90 days

Trial Locations

Locations (63): P Stradins Clinical University hospital, Departement of Anesthesiology
🇱🇻
Riga, Latvia
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-Mureş, Romania
European Institute of Oncology,Anaesthesia and Intensive Care
🇮🇹
Milano, Italy
Azienda Ospedaliera Padova, Anesthesia and Intensive Care Clinic, Department of Pharmacology and Anesthesiology
🇮🇹
Padova, Italy
Cliniques Universitaires Saint Luc
🇧🇪
Brussels, Belgium
Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate
🇮🇹
Genoa, Italy
University Hospital Bonn, Anesthesiology
🇩🇪
Bonn, Germany
Hôpital Pitié-Salpêtrière, Anesthesiology and Critical Care
🇫🇷
Paris, France
University Hospital centre "Mother Theresa" Anesthesia & critical Care
🇦🇱
Tirana, Albania
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
🇨🇿
Usti Nad Labem, Czechia
Tartu University Hospital Clinic of Anaesthesiology and Intensive Care
🇪🇪
Tartu, Estonia
MISEK Kft., Anaesthesiology and Intensive Care Unit
🇭🇺
Miskolc, Hungary
S.Orsola-Malpighi
🇮🇹
Bologna, Italy
Azienda Ospedaliera S. Croce e Carle, Anesthesia
🇮🇹
Cuneo, Italy
University of Milano, Ospedale San Paolo Dpt Of Anaesthesia and Intensive Care
🇮🇹
Milano, Italy
Azienda USL n. 5 di Pisa Ospedale F. Lotti Anestesia e Rianimazione
🇮🇹
Pontedera, Italy
University Of Insubria
🇮🇹
Varese, Italy
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
Hospitais da Universidade de Coimbra, EPE. Departement of Anesthesiology
🇵🇹
Coimbra, Portugal
ZithaKlinik, Anaesthesiology and Intensive Care
🇱🇺
Luxembourg, Luxembourg
Hospital General Universitario Alicante, Anaesthesiology
🇪🇸
Alicante, Spain
10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy, Anaesthesiology and Intensive Care
🇵🇱
Bydgoszcz, Poland
Krasnoyarsk State Medical University,Anesthesiology and Intensive Care
🇷🇺
Krasnoyarsk, Russian Federation
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
Corporació Sanitària Parc Taulí, Anaesthesiology
🇪🇸
Barcelona, Spain
Fundació Puigvert Anaesthesiology
🇪🇸
Barcelona, Spain
Hospital General de La Palma, Anestesiología y Reanimación
🇪🇸
Breña Alta, Spain
Hospital de Denia,Anesthesia and Intensive Care
🇪🇸
Denia, Spain
Hospital 12 Octubre, Anaesthesiology
🇪🇸
Madrid, Spain
Hospital San Jorge, Anaesthesiology
🇪🇸
Huesca, Spain
Ospedale Regionale di Lugano, Anestesia
🇨🇭
Lugano, Switzerland
Hospital del Tajo Anaesthesia and Reanimation
🇪🇸
Madrid, Spain
Fundacio Althaia, Anaesthesiology
🇪🇸
Manresa, Spain
Hospital Son Llatzer, Anaesthesiology
🇪🇸
Palma de Mallorca, Spain
Hospital Universitario de Móstoles, anestesiología y Reanimación
🇪🇸
Madrid, Spain
Virgen del Rocio General Universitary Hospital;Anaesthesiology
🇪🇸
Seville, Spain
Hospital Clínic Universitari de València, Anestesiología y Reanimación
🇪🇸
Valencia, Spain
Medical Faculty of Istanbul, Istanbul University, Anaesthesiology
🇹🇷
Istanbul, Turkey
St.Katherine Hospital of Cardiology Anesthesiology & Pain Treatment
🇺🇦
Odessa, Ukraine
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
Hospital Clinic, Anaesthesiology
🇪🇸
Barcelona, Spain
Hospital Arnau de Vilanova Departement of Anesthesiology
🇪🇸
Lleida, Spain
Hospital Santa Maria, Departement of Anesthesiology
🇪🇸
Lleida, Spain
Hospital Universitario de La Princesa, Anesthesiology
🇪🇸
Madrid, Spain
Clinica Universidad de Navarra, Anaesthesia
🇪🇸
Pamplona, Spain
Hospital Universitario Marques De Valdecilla
🇪🇸
Santander, Spain
Consorcio Hospital General Universitario, Anesthesiology, Critical Care and Pain Relief Unit
🇪🇸
Valencia, Spain
Hospital Universitario Rio Hortgea, Anaesthesia and Surgical Critical Care
🇪🇸
Valladolid, Spain
Hospital Sant Pau, Anaesthesiology
🇪🇸
Barcelona, Spain
Parc de Salut Mar, Anesthesiology
🇪🇸
Barcelona, Spain
Vall d'Hebron University Hospital, Anaesthesiology
🇪🇸
Barcelona, Spain
Universitätsmedizin Mainz, Departement of Anesthesiology
🇩🇪
Mainz, Germany
Hospital Universitari Germans Trias i Pujol, Anaesthesiology
🇪🇸
Badalona, Spain