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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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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

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

Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| In-patient Adult Non-obstetricSurgical<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Postoperative in-hospital stay up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Operative surgical procedures, Postoperative pulmonary complications (PPC), Epidemiological Study, ARISCAT score, Risk Score, Europe, PERISCOPE, observational study, 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, Prospective Evaluation, nonobstetric in-hospital surgical procedure, general or regional anaesthesia, continued 7-day period recruitment