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

April 20, 2011
March 4, 2014
May 2011
August 2011   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01346709 on ClinicalTrials.gov Archive Site
  • 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
  • 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.
Not Provided
Not Provided
 
Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

In-patient adult non-obstetric surgery

  • Complication of Surgical Procedure
  • Acute Respiratory Failure, Adult
  • Postoperative Respiratory Complications
  • Pulmonary Failure
  • Surgical Complications From General Anesthesia
Not Provided
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.


*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5183
September 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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
 
NCT01346709
PERISCOPE
No
European Society of Anaesthesiology
European Society of Anaesthesiology
Not Provided
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
European Society of Anaesthesiology
March 2014

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