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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

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

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	5183 participants
Observational Model:	Cohort
Time Perspective:	Prospective
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 Start Date :	May 2011
Actual Primary Completion Date :	August 2011
Actual Study Completion Date :	September 2011

Groups and Cohorts

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Group/Cohort

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.

Outcome Measures

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Primary Outcome Measures :

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. [ Time Frame: Postoperative in-hospital stay up to 5 weeks ]
   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.

Secondary Outcome Measures :

1. a) Postoperative length of stay [ Time Frame: Postoperative in-hospital stay up to 90 days ]
   Participants will be followed for the duration of in-hospital stay up to 90 days
2. b) In-hospital mortality [ Time Frame: Postoperative in-hospital stay up to 90 days ]
   Participants will be followed for the duration of in-hospital stay up to 90 days

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

In-patient adult non-obstetric surgery

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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 63 Study Locations

Sponsors and Collaborators

European Society of Anaesthesiology

Investigators

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	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
Study Chair:	Valentin Mazo, MD	Hospital Universitari Germans Trias I Pujol, Barcelona, Spain
Principal Investigator:	Andreas Hoeft, MD	University Hospital, Bonn

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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 

European Society of Anaesthesiology website 

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 study. Eur J Anaesthesiol. 2015 Jul;32(7):458-70. doi: 10.1097/EJA.0000000000000223.

Responsible Party:	European Society of Anaesthesiology
ClinicalTrials.gov Identifier:	NCT01346709 History of Changes
Other Study ID Numbers:	PERISCOPE
First Posted:	May 3, 2011
Last Update Posted:	March 5, 2014
Last Verified:	March 2014

Keywords provided by European Society of Anaesthesiology:

Aspiration Pneumonitis; 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; Cardiopulmonary edema; Prospective Evaluation; nonobstetric in-hospital surgical procedure; general or regional anaesthesia; continued 7-day period recruitment

Additional relevant MeSH terms:

Respiratory Insufficiency; Respiratory Distress Syndrome, Adult; Respiration Disorders; Respiratory Tract Diseases; Lung Diseases