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

NCT01346709 | Completed Results

• 1 other identifier: PERISCOPE
• Study Type: observational
• Target: 5,450
• Locations: 20 countries
• Sites: 38

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• a) Postoperative Length of Stay

  Postoperative in-hospital stay up to 90 days

• b) In-hospital Mortality

  Postoperative in-hospital stay up to 90 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In-patient adult non-obstetric surgery

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Society of Anaesthesiology: lead

Study Sites (63)

University Hospital centre "Mother Theresa" Anesthesia & critical Care

Tirana, Albania

Location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

General Hospital "Prim.dr Abdulah Nakas" Departement of Anaesthesia and intensive care

Sarajevo, Bosnia and Herzegovina

Location

Heart Center

Sarajevo, Bosnia and Herzegovina

Location

University Hospital Rijeka Anaesthesiology and Intensive care

Rijeka, Croatia

Location

Faculty Hospital Brno, department of Anaesthesiology and Intensive Care Medicine

Brno, Czechia

Location

Masaryks hospital Usti nad labem, Dept. of Anesthesia and intensive medicine

Ústí nad Labem, Czechia

Location

Tartu University Hospital Clinic of Anaesthesiology and Intensive Care

Tartu, Estonia

Location

Hôpital Pitié-Salpêtrière, Anesthesiology and Critical Care

Paris, France

Location

University Hospital Bonn, Anesthesiology

Bonn, Germany

Location

Klinikum Darmstadt GmbH Anesthesiology, Intensive Care and pain medicin

Darmstadt, Germany

Location

University Hospital Carl Gustav Carus, Dresden University of Technonology, Department of Anesthesiology and Intensive Care Therapy

Dresden, Germany

Location

Universitätsmedizin Mainz, Departement of Anesthesiology

Mainz, Germany

Location

MISEK Kft., Anaesthesiology and Intensive Care Unit

Miskolc, Hungary

Location

S.Orsola-Malpighi

Bologna, Italy

Location

Azienda Ospedaliera S. Croce e Carle, Anesthesia

Cuneo, Italy

Location

Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate

Genoa, Italy

Location

European Institute of Oncology,Anaesthesia and Intensive Care

Milan, Italy

Location

University of Milano, Ospedale San Paolo Dpt Of Anaesthesia and Intensive Care

Milan, Italy

Location

Azienda Ospedaliera Padova, Anesthesia and Intensive Care Clinic, Department of Pharmacology and Anesthesiology

Padua, Italy

Location

Azienda USL n. 5 di Pisa Ospedale F. Lotti Anestesia e Rianimazione

Pontedera, Italy

Location

University Of Insubria

Varese, Italy

Location

P Stradins Clinical University hospital, Departement of Anesthesiology

Riga, Latvia

Location

Hospital of Lithuanian University of Health Sciences, Clinic of Anaesthesiology

Kaunas, Lithuania

Location

Vilnius University Hospital Santariskiu Clinics, Center of Anesthesiology, Intensive Care and Pain Treatment

Vilnius, Lithuania

Location

ZithaKlinik, Anaesthesiology and Intensive Care

Luxembourg, Luxembourg

Location

10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy, Anaesthesiology and Intensive Care

Bydgoszcz, Poland

Location

Hospitais da Universidade de Coimbra, EPE. Departement of Anesthesiology

Coimbra, Portugal

Location

Centro Hospitalar de Lisboa Ocidental, Serviço de Anestesia

Lisbon, Portugal

Location

Hospital Fernando Fonseca,Anesthesiology

Lisbon, Portugal

Location

Instituto Português de Oncologia, Departement of Anesthesiology

Porto, Portugal

Location

Emergency Institute of Cardiovascular Diseases Prof Dr C. C. Iliescu, Cardiac Anesthesia and Intensive Care

Bucharest, Romania

Location

Emergency Clinical Hospital of Constanta, Department of Anaesthesiology and Intensive Care

Constanța, Romania

Location

Emergency County Hospital Clinic of Anesthesia and Intensive Care, Intensive Care and Anesthesiology

Târgu Mureş, Romania

Location

Krasnoyarsk State Medical University,Anesthesiology and Intensive Care

Krasnoyarsk, Russia

Location

Hospital General Universitario Alicante, Anaesthesiology

Alicante, Spain

Location

Hospital Universitari Germans Trias i Pujol, Anaesthesiology

Badalona, Spain

Location

Corporació Sanitària Parc Taulí, Anaesthesiology

Barcelona, Spain

Location

Fundació Puigvert Anaesthesiology

Barcelona, Spain

Location

Hospital Clinic, Anaesthesiology

Barcelona, Spain

Location

Hospital Sant Pau, Anaesthesiology

Barcelona, Spain

Location

Parc de Salut Mar, Anesthesiology

Barcelona, Spain

Location

Vall d'Hebron University Hospital, Anaesthesiology

Barcelona, Spain

Location

Hospital General de La Palma, Anestesiología y Reanimación

Breña Alta, Spain

Location

Hospital de Denia,Anesthesia and Intensive Care

Denia, Spain

Location

Hospital San Jorge, Anaesthesiology

Huesca, Spain

Location

Hospital Arnau de Vilanova Departement of Anesthesiology

Lleida, Spain

Location

Hospital Santa Maria, Departement of Anesthesiology

Lleida, Spain

Location

Hospital 12 Octubre, Anaesthesiology

Madrid, Spain

Location

Hospital del Tajo Anaesthesia and Reanimation

Madrid, Spain

Location

Hospital Universitario de La Princesa, Anesthesiology

Madrid, Spain

Location

Hospital Universitario de Móstoles, anestesiología y Reanimación

Madrid, Spain

Location

Fundacio Althaia, Anaesthesiology

Manresa, Spain

Location

Hospital Son Llatzer, Anaesthesiology

Palma de Mallorca, Spain

Location

Clinica Universidad de Navarra, Anaesthesia

Pamplona, Spain

Location

Hospital Universitario Marques De Valdecilla

Santander, Spain

Location

Virgen del Rocio General Universitary Hospital;Anaesthesiology

Seville, Spain

Location

Consorcio Hospital General Universitario, Anesthesiology, Critical Care and Pain Relief Unit

Valencia, Spain

Location

Hospital Clínic Universitari de València, Anestesiología y Reanimación

Valencia, Spain

Location

Hospital Universitario Rio Hortgea, Anaesthesia and Surgical Critical Care

Valladolid, Spain

Location

Ospedale Regionale di Lugano, Anestesia

Lugano, Switzerland

Location

Medical Faculty of Istanbul, Istanbul University, Anaesthesiology

Istanbul, Turkey (Türkiye)

Location

St.Katherine Hospital of Cardiology Anesthesiology & Pain Treatment

Odesa, Ukraine

Location

Related Publications (5)

• 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.

  PMID: 21544025 BACKGROUND

• 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.

  PMID: 21045639 BACKGROUND

• 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.

  PMID: 26020123 RESULT

• 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.

  PMID: 24901240 RESULT

• 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.

  PMID: 30431500 DERIVED

Related 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

MeSH Terms

Conditions

Respiratory Insufficiency; Acute Lung Injury; Respiratory Distress Syndrome; Pleural Effusion; Pulmonary Atelectasis; Pneumothorax; Bronchial Spasm; Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Injury; Lung Diseases; Pleural Diseases; Bronchial Diseases; Pneumonia; Respiratory Tract Infections; Infections

Results Point of Contact

• Title: Brigitte Leva, Research Team Leader
• Organization: European Society of anaesthesiology

research@esahq.org

+3222109414

Study Officials

• Jaume Canet, MD

  Hospital Universitari Germans Trias I Pujol, Barcelona, Spain

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

• Valentin Mazo, MD

  Hospital Universitari Germans Trias I Pujol, Barcelona, Spain

  STUDY CHAIR

• Andreas Hoeft, MD

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: May 3, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 5, 2022
• Results First Posted: April 5, 2022

Record last verified: 2015-10

Locations

PT (4); RO (3); CH (1); TU (1); IT (8); CR (1); DE (4); LI (2); PL (1); BO (2); AL (1); UA (1); LA (1); LU (1); RU (1); ES (1); BE (1); HU (1); FR (1); CZ (2)