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

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ClinicalTrials.gov Identifier: NCT01346709
Recruitment Status : Completed
First Posted : May 3, 2011
Last Update Posted : March 5, 2014
Sponsor:
Information provided by (Responsible Party):
European Society of Anaesthesiology

Study Description
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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

Resource links provided by the National Library of Medicine


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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346709


Locations
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Sponsors and Collaborators
European Society of Anaesthesiology
Investigators
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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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Additional Information:

Publications:

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

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Responsible Party: European Society of Anaesthesiology
ClinicalTrials.gov Identifier: NCT01346709    
Other Study ID Numbers: PERISCOPE
First Posted: May 3, 2011    Key Record Dates
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:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases