Clinical trial NCT01346709: Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe
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 type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: European Society of Anaesthesiology
Sponsor class: OTHER
First posted: 2011-05-03
Enrollment: 5450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In-patient adult non-obstetric surgery

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Main Outcome, Defined as a Postoperative Pulmonary Complications (PPC), Will be a Composite of the In-hospital Fatal or Non-fatal Postoperative Events.
timeFrame: Postoperative in-hospital stay up to 5 weeks
Secondary outcomes:
measure: a) Postoperative Length of Stay
timeFrame: Postoperative in-hospital stay up to 90 days
measure: b) In-hospital Mortality
timeFrame: Postoperative in-hospital stay up to 90 days
Other outcomes:
Locations:
city: Tirana
country: Albania
facility: University Hospital centre "Mother Theresa" Anesthesia & critical Care
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Sarajevo
country: Bosnia and Herzegovina
facility: General Hospital "Prim.dr Abdulah Nakas" Departement of Anaesthesia and intensive care
city: Sarajevo
country: Bosnia and Herzegovina
facility: Heart Center
city: Rijeka
country: Croatia
facility: University Hospital Rijeka Anaesthesiology and Intensive care
city: Brno
country: Czechia
facility: Faculty Hospital Brno, department of Anaesthesiology and Intensive Care Medicine
city: Usti Nad Labem
country: Czechia
facility: Masaryks hospital Usti nad labem, Dept. of Anesthesia and intensive medicine
city: Tartu
country: Estonia
facility: Tartu University Hospital Clinic of Anaesthesiology and Intensive Care
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière, Anesthesiology and Critical Care
city: Bonn
country: Germany
facility: University Hospital Bonn, Anesthesiology
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt GmbH Anesthesiology, Intensive Care and pain medicin
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus, Dresden University of Technonology, Department of Anesthesiology and Intensive Care Therapy
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz, Departement of Anesthesiology
city: Miskolc
country: Hungary
facility: MISEK Kft., Anaesthesiology and Intensive Care Unit
city: Bologna
country: Italy
facility: S.Orsola-Malpighi
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S. Croce e Carle, Anesthesia
city: Genoa
country: Italy
facility: Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate
city: Milano
country: Italy
facility: European Institute of Oncology,Anaesthesia and Intensive Care
city: Milano
country: Italy
facility: University of Milano, Ospedale San Paolo Dpt Of Anaesthesia and Intensive Care
city: Padova
country: Italy
facility: Azienda Ospedaliera Padova, Anesthesia and Intensive Care Clinic, Department of Pharmacology and Anesthesiology
city: Pontedera
country: Italy
facility: Azienda USL n. 5 di Pisa Ospedale F. Lotti Anestesia e Rianimazione
city: Varese
country: Italy
facility: University Of Insubria
city: Riga
country: Latvia
facility: P Stradins Clinical University hospital, Departement of Anesthesiology
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences, Clinic of Anaesthesiology
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinics, Center of Anesthesiology, Intensive Care and Pain Treatment
city: Luxembourg
country: Luxembourg
facility: ZithaKlinik, Anaesthesiology and Intensive Care
city: Bydgoszcz
country: Poland
facility: 10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy, Anaesthesiology and Intensive Care
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra, EPE. Departement of Anesthesiology
city: Lisbon
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental, Serviço de Anestesia
city: Lisbon
country: Portugal
facility: Hospital Fernando Fonseca,Anesthesiology
city: Porto
country: Portugal
facility: Instituto Português de Oncologia, Departement of Anesthesiology
city: Bucharest
country: Romania
facility: Emergency Institute of Cardiovascular Diseases Prof Dr C. C. Iliescu, Cardiac Anesthesia and Intensive Care
city: Constanta
country: Romania
facility: Emergency Clinical Hospital of Constanta, Department of Anaesthesiology and Intensive Care
city: Târgu-Mureş
country: Romania
facility: Emergency County Hospital Clinic of Anesthesia and Intensive Care, Intensive Care and Anesthesiology
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk State Medical University,Anesthesiology and Intensive Care
city: Alicante
country: Spain
facility: Hospital General Universitario Alicante, Anaesthesiology
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol, Anaesthesiology
city: Barcelona
country: Spain
facility: Corporació Sanitària Parc Taulí, Anaesthesiology
city: Barcelona
country: Spain
facility: Fundació Puigvert Anaesthesiology
city: Barcelona
country: Spain
facility: Hospital Clinic, Anaesthesiology
city: Barcelona
country: Spain
facility: Hospital Sant Pau, Anaesthesiology
city: Barcelona
country: Spain
facility: Parc de Salut Mar, Anesthesiology
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital, Anaesthesiology
city: Breña Alta
country: Spain
facility: Hospital General de La Palma, Anestesiología y Reanimación
city: Denia
country: Spain
facility: Hospital de Denia,Anesthesia and Intensive Care
city: Huesca
country: Spain
facility: Hospital San Jorge, Anaesthesiology
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova Departement of Anesthesiology
city: Lleida
country: Spain
facility: Hospital Santa Maria, Departement of Anesthesiology
city: Madrid
country: Spain
facility: Hospital 12 Octubre, Anaesthesiology
city: Madrid
country: Spain
facility: Hospital del Tajo Anaesthesia and Reanimation
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa, Anesthesiology
city: Madrid
country: Spain
facility: Hospital Universitario de Móstoles, anestesiología y Reanimación
city: Manresa
country: Spain
facility: Fundacio Althaia, Anaesthesiology
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer, Anaesthesiology
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra, Anaesthesia
city: Santander
country: Spain
facility: Hospital Universitario Marques De Valdecilla
city: Seville
country: Spain
facility: Virgen del Rocio General Universitary Hospital;Anaesthesiology
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario, Anesthesiology, Critical Care and Pain Relief Unit
city: Valencia
country: Spain
facility: Hospital Clínic Universitari de València, Anestesiología y Reanimación
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortgea, Anaesthesia and Surgical Critical Care
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano, Anestesia
city: Istanbul
country: Turkey
facility: Medical Faculty of Istanbul, Istanbul University, Anaesthesiology
city: Odessa
country: Ukraine
facility: St.Katherine Hospital of Cardiology Anesthesiology & Pain Treatment
Study officials:
affiliation: Hospital Universitari Germans Trias I Pujol, Barcelona, Spain
name: Jaume Canet, MD
role: STUDY_DIRECTOR
affiliation: Fundació Puigvert (IUNA), Barcelona, Spain
name: Sergi Sabaté, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Groupe Hospitalier Pitie-Salpetriere
name: Olivier Langeron, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Carl Gustav Carus Dresden University of Technology, Dresden, Germany
name: Marcelo Gama de Abreu, MD,PhD,DEAA
role: PRINCIPAL_INVESTIGATOR
affiliation: Parc de Salut Mar Anaesthesiology Research Group IMIM, Universitat Autònoma de Barcelona, Barcelona, Spain
name: Lluís Gallart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universitario de Valencia, Valencia, Spain
name: Francisco Javier Belda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Genoa, Genoa, Italy - San Martino Hospital, Genoa, Italy
name: Paolo Pelosi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Germans Trias I Pujol, Barcelona, Spain
name: Valentin Mazo, MD
role: STUDY_CHAIR
affiliation: University Hospital, Bonn
name: Andreas Hoeft, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.