Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe (PERISCOPE)
Complication of Surgical Procedure
Acute Respiratory Failure, Adult
Postoperative Respiratory Complications
Surgical Complications From General Anesthesia
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe: Predicting Postoperative Pulmonary Complications in Europe: a 7-day Data Collection, Prospective, Observational Study|
- The main outcome, defined as a postoperative pulmonary complications (PPC), will be a composite of the in-hospital fatal or non-fatal postoperative events. [ Time Frame: Postoperative in-hospital stay up to 5 weeks ] [ Designated as safety issue: No ]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.
- a) Postoperative length of stay [ Time Frame: Postoperative in-hospital stay up to 90 days ] [ Designated as safety issue: No ]Participants will be followed for the duration of in-hospital stay up to 90 days
- b) In-hospital mortality [ Time Frame: Postoperative in-hospital stay up to 90 days ] [ Designated as safety issue: No ]Participants will be followed for the duration of in-hospital stay up to 90 days
|Study Start Date:||May 2011|
|Study Completion Date:||September 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346709
Show 63 Study Locations
|Study Director:||Jaume Canet, MD||Hospital Universitari Germans Trias I Pujol, Barcelona, Spain|
|Principal Investigator:||Sergi Sabaté, MD, PhD||Fundació Puigvert (IUNA), Barcelona, Spain|
|Principal Investigator:||Olivier Langeron, MD, PhD||Hôpital de la Pitié Salpêtrière, Paris, France|
|Principal Investigator:||Marcelo Gama de Abreu, MD,PhD,DEAA||University Hospital Carl Gustav Carus Dresden University of Technology, Dresden, Germany|
|Principal Investigator:||Lluís Gallart, MD||Parc de Salut Mar Anaesthesiology Research Group IMIM, Universitat Autònoma de Barcelona, Barcelona, Spain|
|Principal Investigator:||Francisco Javier Belda, MD||Hospital Clínico Universitario de Valencia, Valencia, Spain|
|Principal Investigator:||Paolo Pelosi, MD, PhD||University of Genoa, Genoa, Italy - San Martino Hospital, Genoa, Italy|
|Study Chair:||Valentin Mazo, MD||Hospital Universitari Germans Trias I Pujol, Barcelona, Spain|
|Principal Investigator:||Andreas Hoeft, MD||University Hospital, Bonn|