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

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

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Actual): 5450

Contacts and Locations

Study Locations

• Albania
  • Tirana, Albania
    • University Hospital centre "Mother Theresa" Anesthesia & critical Care
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint Luc
• Bosnia and Herzegovina
  • Sarajevo, Bosnia and Herzegovina
    • General Hospital "Prim.dr Abdulah Nakas" Departement of Anaesthesia and intensive care
  • Sarajevo, Bosnia and Herzegovina
    • Heart Center
• Croatia
  • Rijeka, Croatia
    • University Hospital Rijeka Anaesthesiology and Intensive care
• Czechia
  • Brno, Czechia
    • Faculty Hospital Brno, department of Anaesthesiology and Intensive Care Medicine
  • Usti Nad Labem, Czechia
    • Masaryks hospital Usti nad labem, Dept. of Anesthesia and intensive medicine
• Estonia
  • Tartu, Estonia
    • Tartu University Hospital Clinic of Anaesthesiology and Intensive Care
• France
  • Paris, France
    • Hôpital Pitié-Salpêtrière, Anesthesiology and Critical Care
• Germany
  • Bonn, Germany
    • University Hospital Bonn, Anesthesiology
  • Darmstadt, Germany
    • Klinikum Darmstadt GmbH Anesthesiology, Intensive Care and pain medicin
  • Dresden, Germany
    • University Hospital Carl Gustav Carus, Dresden University of Technonology, Department of Anesthesiology and Intensive Care Therapy
  • Mainz, Germany
    • Universitätsmedizin Mainz, Departement of Anesthesiology
• Hungary
  • Miskolc, Hungary
    • MISEK Kft., Anaesthesiology and Intensive Care Unit
• Italy
  • Bologna, Italy
    • S.Orsola-Malpighi
  • Cuneo, Italy
    • Azienda Ospedaliera S. Croce e Carle, Anesthesia
  • Genoa, Italy
    • Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate
  • Milano, Italy
    • European Institute of Oncology,Anaesthesia and Intensive Care
  • Milano, Italy
    • University of Milano, Ospedale San Paolo Dpt Of Anaesthesia and Intensive Care
  • Padova, Italy
    • Azienda Ospedaliera Padova, Anesthesia and Intensive Care Clinic, Department of Pharmacology and Anesthesiology
  • Pontedera, Italy
    • Azienda USL n. 5 di Pisa Ospedale F. Lotti Anestesia e Rianimazione
  • Varese, Italy
    • University of Insubria
• Latvia
  • Riga, Latvia
    • P Stradins Clinical University hospital, Departement of Anesthesiology
• Lithuania
  • Kaunas, Lithuania
    • Hospital of Lithuanian University of Health Sciences, Clinic of Anaesthesiology
  • Vilnius, Lithuania
    • Vilnius University Hospital Santariskiu Clinics, Center of Anesthesiology, Intensive Care and Pain Treatment
• Luxembourg
  • Luxembourg, Luxembourg
    • ZithaKlinik, Anaesthesiology and Intensive Care
• Poland
  • Bydgoszcz, Poland
    • 10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy, Anaesthesiology and Intensive Care
• Portugal
  • Coimbra, Portugal
    • Hospitais da Universidade de Coimbra, EPE. Departement of Anesthesiology
  • Lisbon, Portugal
    • Centro Hospitalar de Lisboa Ocidental, Serviço de Anestesia
  • Lisbon, Portugal
    • Hospital Fernando Fonseca,Anesthesiology
  • Porto, Portugal
    • Instituto Português de Oncologia, Departement of Anesthesiology
• Romania
  • Bucharest, Romania
    • Emergency Institute of Cardiovascular Diseases Prof Dr C. C. Iliescu, Cardiac Anesthesia and Intensive Care
  • Constanta, Romania
    • Emergency Clinical Hospital of Constanta, Department of Anaesthesiology and Intensive Care
  • Târgu-Mureş, Romania
    • Emergency County Hospital Clinic of Anesthesia and Intensive Care, Intensive Care and Anesthesiology
• Russian Federation
  • Krasnoyarsk, Russian Federation
    • Krasnoyarsk State Medical University,Anesthesiology and Intensive Care
• Spain
  • Alicante, Spain
    • Hospital General Universitario Alicante, Anaesthesiology
  • Badalona, Spain
    • Hospital Universitari Germans Trias i Pujol, Anaesthesiology
  • Barcelona, 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
  • Breña Alta, Spain
    • Hospital General de La Palma, Anestesiología y Reanimación
  • Denia, Spain
    • Hospital de Denia,Anesthesia and Intensive Care
  • Huesca, Spain
    • Hospital San Jorge, Anaesthesiology
  • Lleida, Spain
    • Hospital Arnau de Vilanova Departement of Anesthesiology
  • Lleida, Spain
    • Hospital Santa Maria, Departement of Anesthesiology
  • Madrid, 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
  • Manresa, Spain
    • Fundacio Althaia, Anaesthesiology
  • Palma de Mallorca, Spain
    • Hospital Son Llatzer, Anaesthesiology
  • Pamplona, Spain
    • Clinica Universidad de Navarra, Anaesthesia
  • Santander, Spain
    • Hospital Universitario Marques de Valdecilla
  • Seville, Spain
    • Virgen del Rocio General Universitary Hospital;Anaesthesiology
  • Valencia, Spain
    • Consorcio Hospital General Universitario, Anesthesiology, Critical Care and Pain Relief Unit
  • Valencia, Spain
    • Hospital Clínic Universitari de València, Anestesiología y Reanimación
  • Valladolid, Spain
    • Hospital Universitario Rio Hortgea, Anaesthesia and Surgical Critical Care
• Switzerland
  • Lugano, Switzerland
    • Ospedale Regionale di Lugano, Anestesia
• Turkey
  • Istanbul, Turkey
    • Medical Faculty of Istanbul, Istanbul University, Anaesthesiology
• Ukraine
  • Odessa, Ukraine
    • St.Katherine Hospital of Cardiology Anesthesiology & Pain Treatment

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

In-patient adult non-obstetric surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: European Society of Anaesthesiology
• Investigators: 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

Publications and helpful links

General Publications

• Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate 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.
• Canet J, Hardman J, Sabate 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. No abstract available.
• Canet J, Sabate 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 study. Eur J Anaesthesiol. 2015 Jul;32(7):458-70. doi: 10.1097/EJA.0000000000000223.
• Mazo V, Sabate 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.0000000000000334.
• Russotto V, Sabate S, Canet J; PERISCOPE group; of the European Society of Anaesthesiology (ESA) Clinical Trial Network. Development of a prediction model for postoperative pneumonia: A multicentre prospective observational study. Eur J Anaesthesiol. 2019 Feb;36(2):93-104. doi: 10.1097/EJA.0000000000000921.

Helpful Links

• The aim of the PERISCOPE study is to validate a simple score to predict postoperative pulmonary complications. This score has recently been published in Anesthesiology and you can access via this link
• European Society of Anaesthesiology website

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: April 20, 2011
• First Submitted That Met QC Criteria: May 2, 2011
• First Posted (Estimate): May 3, 2011

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: observational study; Pleural effusion; Atelectasis; Operative surgical procedures; Postoperative pulmonary complications (PPC); Epidemiological Study; ARISCAT score; Risk Score; Europe; PERISCOPE; Mild respiratory failure; Severe respiratory failure; acute lung injury (ALI); Acute respiratory distress syndrome (ARDS); Suspected pulmonary infection; Pulmonary infiltrate; Pneumothorax; Bronchospasm; Aspiration Pneumonitis; Cardiopulmonary edema; Prospective Evaluation; nonobstetric in-hospital surgical procedure; general or regional anaesthesia; continued 7-day period recruitment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: PERISCOPE