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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

European Society of Anaesthesiology

ClinicalTrials.gov Identifier:

NCT01346709

First received: April 20, 2011

Last updated: February 12, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 20, 2011

Last Updated Date

February 12, 2013

Start Date ^ICMJE

May 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The main outcome, defined as a postoperative pulmonary complications (PPC), will be a composite of the in-hospital fatal or non-fatal postoperative events. [ Time Frame: 3 days to 5 weeks ] [ Designated as safety issue: No ]

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 expected average maximum 5 weeks.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01346709 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

a) Postoperative length of stay [ Time Frame: 3 days to 5 weeks ] [ Designated as safety issue: No ]
Participants will be followed for the duration of in-hospital stay, an expected average of maximum 5 weeks.
b) In-hospital mortality [ Time Frame: up to 5 weeks ] [ Designated as safety issue: No ]
Participants will be followed for the duration of in-hospital stay, an expected average of maximum 5 weeks.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

In-patient adult non-obstetric surgery

Condition ^ICMJE

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

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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.

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

5183

Completion Date

September 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT01346709

Other Study ID Numbers ^ICMJE

PERISCOPE

Has Data Monitoring Committee

Responsible Party

European Society of Anaesthesiology

Study Sponsor ^ICMJE

European Society of Anaesthesiology

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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	Hôpital de la Pitié-Salpêtrière, Paris, France
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 of Bonn Medical School

Information Provided By

European Society of Anaesthesiology

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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