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

NCT ID: NCT01346709

Last Updated: 2022-04-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-09-30

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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Society of Anaesthesiology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jaume Canet, MD

Role: STUDY_DIRECTOR

Hospital Universitari Germans Trias I Pujol, Barcelona, Spain

Sergi Sabaté, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundació Puigvert (IUNA), Barcelona, Spain

Olivier Langeron, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier Pitie-Salpetriere

Marcelo Gama de Abreu, MD,PhD,DEAA

Role: PRINCIPAL_INVESTIGATOR

University Hospital Carl Gustav Carus Dresden University of Technology, Dresden, Germany

Lluís Gallart, MD

Role: PRINCIPAL_INVESTIGATOR

Parc de Salut Mar Anaesthesiology Research Group IMIM, Universitat Autònoma de Barcelona, Barcelona, Spain

Francisco Javier Belda, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario de Valencia, Valencia, Spain

Paolo Pelosi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Genoa, Genoa, Italy - San Martino Hospital, Genoa, Italy

Valentin Mazo, MD

Role: STUDY_CHAIR

Hospital Universitari Germans Trias I Pujol, Barcelona, Spain

Andreas Hoeft, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bonn

Locations

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University Hospital centre "Mother Theresa" Anesthesia & critical Care

Tirana, , Albania

Site Status

Cliniques Universitaires Saint Luc

Brussels, , Belgium

Site Status

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

Sarajevo, , Bosnia and Herzegovina

Site Status

Heart Center

Sarajevo, , Bosnia and Herzegovina

Site Status

University Hospital Rijeka Anaesthesiology and Intensive care

Rijeka, , Croatia

Site Status

Faculty Hospital Brno, department of Anaesthesiology and Intensive Care Medicine

Brno, , Czechia

Site Status

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

Ústí nad Labem, , Czechia

Site Status

Tartu University Hospital Clinic of Anaesthesiology and Intensive Care

Tartu, , Estonia

Site Status

Hôpital Pitié-Salpêtrière, Anesthesiology and Critical Care

Paris, , France

Site Status

University Hospital Bonn, Anesthesiology

Bonn, , Germany

Site Status

Klinikum Darmstadt GmbH Anesthesiology, Intensive Care and pain medicin

Darmstadt, , Germany

Site Status

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

Dresden, , Germany

Site Status

Universitätsmedizin Mainz, Departement of Anesthesiology

Mainz, , Germany

Site Status

MISEK Kft., Anaesthesiology and Intensive Care Unit

Miskolc, , Hungary

Site Status

S.Orsola-Malpighi

Bologna, , Italy

Site Status

Azienda Ospedaliera S. Croce e Carle, Anesthesia

Cuneo, , Italy

Site Status

Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate

Genoa, , Italy

Site Status

European Institute of Oncology,Anaesthesia and Intensive Care

Milan, , Italy

Site Status

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

Milan, , Italy

Site Status

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

Padua, , Italy

Site Status

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

Pontedera, , Italy

Site Status

University Of Insubria

Varese, , Italy

Site Status

P Stradins Clinical University hospital, Departement of Anesthesiology

Riga, , Latvia

Site Status

Hospital of Lithuanian University of Health Sciences, Clinic of Anaesthesiology

Kaunas, , Lithuania

Site Status

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

Vilnius, , Lithuania

Site Status

ZithaKlinik, Anaesthesiology and Intensive Care

Luxembourg, , Luxembourg

Site Status

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

Bydgoszcz, , Poland

Site Status

Hospitais da Universidade de Coimbra, EPE. Departement of Anesthesiology

Coimbra, , Portugal

Site Status

Centro Hospitalar de Lisboa Ocidental, Serviço de Anestesia

Lisbon, , Portugal

Site Status

Hospital Fernando Fonseca,Anesthesiology

Lisbon, , Portugal

Site Status

Instituto Português de Oncologia, Departement of Anesthesiology

Porto, , Portugal

Site Status

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

Bucharest, , Romania

Site Status

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

Constanța, , Romania

Site Status

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

Târgu Mureş, , Romania

Site Status

Krasnoyarsk State Medical University,Anesthesiology and Intensive Care

Krasnoyarsk, , Russia

Site Status

Hospital General Universitario Alicante, Anaesthesiology

Alicante, , Spain

Site Status

Hospital Universitari Germans Trias i Pujol, Anaesthesiology

Badalona, , Spain

Site Status

Corporació Sanitària Parc Taulí, Anaesthesiology

Barcelona, , Spain

Site Status

Fundació Puigvert Anaesthesiology

Barcelona, , Spain

Site Status

Hospital Clinic, Anaesthesiology

Barcelona, , Spain

Site Status

Hospital Sant Pau, Anaesthesiology

Barcelona, , Spain

Site Status

Parc de Salut Mar, Anesthesiology

Barcelona, , Spain

Site Status

Vall d'Hebron University Hospital, Anaesthesiology

Barcelona, , Spain

Site Status

Hospital General de La Palma, Anestesiología y Reanimación

Breña Alta, , Spain

Site Status

Hospital de Denia,Anesthesia and Intensive Care

Denia, , Spain

Site Status

Hospital San Jorge, Anaesthesiology

Huesca, , Spain

Site Status

Hospital Arnau de Vilanova Departement of Anesthesiology

Lleida, , Spain

Site Status

Hospital Santa Maria, Departement of Anesthesiology

Lleida, , Spain

Site Status

Hospital 12 Octubre, Anaesthesiology

Madrid, , Spain

Site Status

Hospital del Tajo Anaesthesia and Reanimation

Madrid, , Spain

Site Status

Hospital Universitario de La Princesa, Anesthesiology

Madrid, , Spain

Site Status

Hospital Universitario de Móstoles, anestesiología y Reanimación

Madrid, , Spain

Site Status

Fundacio Althaia, Anaesthesiology

Manresa, , Spain

Site Status

Hospital Son Llatzer, Anaesthesiology

Palma de Mallorca, , Spain

Site Status

Clinica Universidad de Navarra, Anaesthesia

Pamplona, , Spain

Site Status

Hospital Universitario Marques De Valdecilla

Santander, , Spain

Site Status

Virgen del Rocio General Universitary Hospital;Anaesthesiology

Seville, , Spain

Site Status

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

Valencia, , Spain

Site Status

Hospital Clínic Universitari de València, Anestesiología y Reanimación

Valencia, , Spain

Site Status

Hospital Universitario Rio Hortgea, Anaesthesia and Surgical Critical Care

Valladolid, , Spain

Site Status

Ospedale Regionale di Lugano, Anestesia

Lugano, , Switzerland

Site Status

Medical Faculty of Istanbul, Istanbul University, Anaesthesiology

Istanbul, , Turkey (Türkiye)

Site Status

St.Katherine Hospital of Cardiology Anesthesiology & Pain Treatment

Odesa, , Ukraine

Site Status

Countries

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Albania Belgium Bosnia and Herzegovina Croatia Czechia Estonia France Germany Hungary Italy Latvia Lithuania Luxembourg Poland Portugal Romania Russia Spain Switzerland Turkey (Türkiye) Ukraine

References

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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.

Reference Type BACKGROUND
PMID: 21544025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21045639 (View on PubMed)

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.

Reference Type RESULT
PMID: 26020123 (View on PubMed)

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.

Reference Type RESULT
PMID: 24901240 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30431500 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://journals.lww.com/co-anesthesiology/Abstract/2019/06000/Prediction_of_postoperative_pulmonary.28.aspx

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

https://euroanaesthesia2020.org/

European Society of Anaesthesiology website

Other Identifiers

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PERISCOPE

Identifier Type: -

Identifier Source: org_study_id

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