Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe (PERISCOPE)
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| ClinicalTrials.gov Identifier: NCT01346709 |
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Recruitment Status :
Completed
First Posted : May 3, 2011
Last Update Posted : March 5, 2014
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| Condition or disease |
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| Complication of Surgical Procedure Acute Respiratory Failure, Adult Postoperative Respiratory Complications Pulmonary Failure Surgical Complications From General Anesthesia |
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.
| Study Type : | Observational |
| Actual Enrollment : | 5183 participants |
| 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 |
| Study Start Date : | May 2011 |
| Actual Primary Completion Date : | August 2011 |
| Actual Study Completion Date : | September 2011 |
| Group/Cohort |
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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. |
- 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 ]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 ]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 ]Participants will be followed for the duration of in-hospital stay up to 90 days
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 | 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: | 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 |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | European Society of Anaesthesiology |
| ClinicalTrials.gov Identifier: | NCT01346709 History of Changes |
| Other Study ID Numbers: |
PERISCOPE |
| First Posted: | May 3, 2011 Key Record Dates |
| Last Update Posted: | March 5, 2014 |
| Last Verified: | March 2014 |
Keywords provided by European Society of Anaesthesiology:
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Aspiration Pneumonitis 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 Cardiopulmonary edema Prospective Evaluation nonobstetric in-hospital surgical procedure general or regional anaesthesia continued 7-day period recruitment |
Additional relevant MeSH terms:
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Respiratory Insufficiency Respiratory Distress Syndrome, Adult Respiration Disorders Respiratory Tract Diseases Lung Diseases |