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: March 4, 2014
Last verified: March 2014
  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:


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.


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:

  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
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:
Publications:
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:
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
Aspiration Pneumonitis
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

ClinicalTrials.gov processed this record on September 22, 2014