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

Complication of Surgical Procedure Clinical Trial

— PERISCOPE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346709
• Other study ID #: PERISCOPE
• Status: Completed
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2015
• Source: European Society of Anaesthesiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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_Pulmon ary.20.aspx

TIMEFRAME Participants will be followed for the duration of in-hospital stay, an expected average of maximum 5 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5450
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
European Society of Anaesthesiology

Countries where clinical trial is conducted

Albania,  Belgium,  Bosnia and Herzegovina,  Croatia,  Czechia,  Estonia,  France,  Germany,  Hungary,  Italy,  Latvia,  Lithuania,  Luxembourg,  Poland,  Portugal,  Romania,  Russian Federation,  Spain,  Switzerland,  Turkey,  Ukraine, 

References & Publications (4)

Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, Sabaté 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. — View Citation

Canet J, Hardman J, Sabaté 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. — View Citation

Canet J, Sabaté 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 s — View Citation

Mazo V, Sabaté 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.0000000000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   European Society of Anaesthesiology website
•   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