Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe - Full Text View

Purpose

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


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Health Facilities Respiratory Failure

Genetic and Rare Diseases Information Center resources: Acute Respiratory Distress Syndrome Heinz Body Anemias Respiratory Distress Syndrome, Infant

U.S. FDA Resources

Further study details as provided by European Society of Anaesthesiology:

Primary Outcome Measures:

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 ] [ 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 up to 5 weeks.

Secondary Outcome Measures:

a) Postoperative length of stay [ Time Frame: Postoperative in-hospital stay up to 90 days ] [ Designated as safety issue: No ]
Participants will be followed for the duration of in-hospital stay up to 90 days
b) In-hospital mortality [ Time Frame: Postoperative in-hospital stay up to 90 days ] [ Designated as safety issue: No ]
Participants will be followed for the duration of in-hospital stay up to 90 days


Enrollment:	5183
Study Start Date:	May 2011
Study Completion Date:	September 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Groups/Cohorts

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.

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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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:

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346709

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	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

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 This link exits the ClinicalTrials.gov site

European Society of Anaesthesiology website This link exits the ClinicalTrials.gov site

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.


Responsible Party:	European Society of Anaesthesiology
ClinicalTrials.gov Identifier:	NCT01346709 History of Changes
Other Study ID Numbers:	PERISCOPE
Study First Received:	April 20, 2011
Last Updated:	March 4, 2014
Health Authority:	Albania: Ministry of Health Department of Pharmacy Belgium: Ethics Committee Bosnia: Federal Ministry of Health Croatia: Ethics Committee Czech Republic: Ethics Committee Estonia: Research Ethics Committee Estonia: The State Agency of Medicine France: Institutional Ethical Committee Germany: Ethics Commission Hungary: Institutional Ethics Committee Italy: Ethics Committee Latvia: Institutional Review Board Lithuania: Bioethics Committee Luxembourg: Comite National d'Ethique de Recherche Poland: Ethics Committee Portugal: Ethics Committee for Clinical Research Romania: Ethics Committee Russia: Ethics Committee Spain: Comité Ético de Investigación Clínica Turkey: Ethics Committee

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 Respiration Disorders Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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