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CompletedNCT01346709PERISCOPEUpdated Apr 5, 2022Results posted

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

An observational study in Complication of Surgical Procedure, Acute Respiratory Failure, Adult and Postoperative Respiratory Complications, sponsored by European Society of Anaesthesiology. Completed at 63 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-05.

Sponsored by European Society of Anaesthesiology · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,450
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • 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
03

In context

Respiratory Insufficiency

1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.

This study's enrollment of 5,450 is above the median of 100 across 455 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

European Society of Anaesthesiology is the lead sponsor of 17 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

In-patient adult non-obstetric surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,450 participants (actual)

Groups and 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.

06

What researchers measure

Primary outcomes

  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.

    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.

    Time frame: Postoperative in-hospital stay up to 5 weeks

Secondary outcomes

  1. a) Postoperative Length of Stay

    Participants will be followed for the duration of in-hospital stay up to 90 days

    Time frame: Postoperative in-hospital stay up to 90 days

  2. b) In-hospital Mortality

    Participants will be followed for the duration of in-hospital stay up to 90 days

    Time frame: Postoperative in-hospital stay up to 90 days

07

Results

Posted Apr 5, 2022

Participant flow

1 week chosen by each centre First Sub First Visit 4-Apr-11 Last data entered 25 Oct 2011

Participant flow — Overall Study
MilestoneIn-patient Adult Non-obstetricSurgical
Started5450
Completed5099
Not completed351
Withdrew: Protocol violation35
Withdrew: Lost to follow-up31
Withdrew: Missing data in candidate risk factor285

Outcome measures

PrimaryThe Main Outcome, Defined as a Postoperative Pulmonary Complications (PPC), Will be a Composite of the In-hospital Fatal or Non-fatal Postoperative Events.

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.

Time frame:
Postoperative in-hospital stay up to 5 weeks
Reported as:
Number · Percentage of Participants
The Main Outcome, Defined as a Postoperative Pulmonary Complications (PPC), Will be a Composite of the In-hospital Fatal or Non-fatal Postoperative Events.
Percentage of ParticipantsIn-patient Adult Non-obstetricSurgical
The Main Outcome, Defined as a Postoperative Pulmonary Complications (PPC), Will be a Composite of the In-hospital Fatal or Non-fatal Postoperative Events.7.92 (7.20 to 8.70)
Secondarya) Postoperative Length of Stay

Participants will be followed for the duration of in-hospital stay up to 90 days

Time frame:
Postoperative in-hospital stay up to 90 days
Reported as:
Median · days
a) Postoperative Length of Stay
daysIn-patient Adult Non-obstetricSurgical
a) Postoperative Length of Stay4 (2 to 7)
Secondaryb) In-hospital Mortality

Participants will be followed for the duration of in-hospital stay up to 90 days

Time frame:
Postoperative in-hospital stay up to 90 days
Reported as:
Number · percentage of Participants
b) In-hospital Mortality
percentage of ParticipantsIn-patient Adult Non-obstetricSurgical
b) In-hospital Mortality0.9

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Observational Study Section Not Applicable———

Baseline characteristics

Age, Customized
Age, Customized(participants)In-patient Adult Non-obstetricSurgical
<=50years1763
51-80years2944
>80years392
Age, Customized
Age, Customized(years)In-patient Adult Non-obstetricSurgical
Age Median59.1 (44.9 to 70.9)
Sex: Female, Male
Sex: Female, Male(Participants)In-patient Adult Non-obstetricSurgical
Female2493
Male2606
Body Mass Index
Body Mass Index(kg/m^2)In-patient Adult Non-obstetricSurgical
Median26.2 (23.4 to 29.4)
Smoking status
Smoking status(participants)In-patient Adult Non-obstetricSurgical
Never Smoker2674
Former Smoker1245
Current Smoker1180
Chronic obstructive pulmonary disease (COPD)
Chronic obstructive pulmonary disease (COPD)(participants)In-patient Adult Non-obstetricSurgical
COPD = yes517
COPD = no4582
Functional Status
Functional Status(participants)In-patient Adult Non-obstetricSurgical
Independant4561
Partally/totally dependant538
Hypertension
Hypertension(participants)In-patient Adult Non-obstetricSurgical
Hypertension = yes2191
Hypertension = no2908

15 further baseline measures are reported on the registry.

08

Study locations

63 sites
  • University Hospital centre "Mother Theresa" Anesthesia & critical Care
    Tirana, Albania
  • Cliniques Universitaires Saint Luc
    Brussels, 1200, Belgium
  • General Hospital "Prim.dr Abdulah Nakas" Departement of Anaesthesia and intensive care
    Sarajevo, Bosnia and Herzegovina
  • Heart Center
    Sarajevo, Bosnia and Herzegovina
  • University Hospital Rijeka Anaesthesiology and Intensive care
    Rijeka, Croatia
  • Faculty Hospital Brno, department of Anaesthesiology and Intensive Care Medicine
    Brno, Czechia
  • Masaryks hospital Usti nad labem, Dept. of Anesthesia and intensive medicine
    Usti Nad Labem, Czechia
  • Tartu University Hospital Clinic of Anaesthesiology and Intensive Care
    Tartu, Estonia
  • Hôpital Pitié-Salpêtrière, Anesthesiology and Critical Care
    Paris, France
  • University Hospital Bonn, Anesthesiology
    Bonn, Germany
  • Klinikum Darmstadt GmbH Anesthesiology, Intensive Care and pain medicin
    Darmstadt, Germany
  • University Hospital Carl Gustav Carus, Dresden University of Technonology, Department of Anesthesiology and Intensive Care Therapy
    Dresden, Germany
  • Universitätsmedizin Mainz, Departement of Anesthesiology
    Mainz, Germany
  • MISEK Kft., Anaesthesiology and Intensive Care Unit
    Miskolc, Hungary
  • S.Orsola-Malpighi
    Bologna, Italy
  • Azienda Ospedaliera S. Croce e Carle, Anesthesia
    Cuneo, Italy
  • Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate
    Genoa, Italy
  • European Institute of Oncology,Anaesthesia and Intensive Care
    Milano, Italy
  • University of Milano, Ospedale San Paolo Dpt Of Anaesthesia and Intensive Care
    Milano, Italy
  • Azienda Ospedaliera Padova, Anesthesia and Intensive Care Clinic, Department of Pharmacology and Anesthesiology
    Padova, Italy
  • Azienda USL n. 5 di Pisa Ospedale F. Lotti Anestesia e Rianimazione
    Pontedera, Italy
  • University Of Insubria
    Varese, Italy
  • P Stradins Clinical University hospital, Departement of Anesthesiology
    Riga, Latvia
  • Hospital of Lithuanian University of Health Sciences, Clinic of Anaesthesiology
    Kaunas, Lithuania
  • Vilnius University Hospital Santariskiu Clinics, Center of Anesthesiology, Intensive Care and Pain Treatment
    Vilnius, Lithuania
  • ZithaKlinik, Anaesthesiology and Intensive Care
    Luxembourg, Luxembourg
  • 10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy, Anaesthesiology and Intensive Care
    Bydgoszcz, Poland
  • Hospitais da Universidade de Coimbra, EPE. Departement of Anesthesiology
    Coimbra, Portugal
  • Centro Hospitalar de Lisboa Ocidental, Serviço de Anestesia
    Lisbon, Portugal
  • Hospital Fernando Fonseca,Anesthesiology
    Lisbon, Portugal
  • Instituto Português de Oncologia, Departement of Anesthesiology
    Porto, Portugal
  • Emergency Institute of Cardiovascular Diseases Prof Dr C. C. Iliescu, Cardiac Anesthesia and Intensive Care
    Bucharest, Romania
  • Emergency Clinical Hospital of Constanta, Department of Anaesthesiology and Intensive Care
    Constanta, Romania
  • Emergency County Hospital Clinic of Anesthesia and Intensive Care, Intensive Care and Anesthesiology
    Târgu-Mureş, Romania
  • Krasnoyarsk State Medical University,Anesthesiology and Intensive Care
    Krasnoyarsk, Russian Federation
  • Hospital General Universitario Alicante, Anaesthesiology
    Alicante, Spain
  • Hospital Universitari Germans Trias i Pujol, Anaesthesiology
    Badalona, Spain
  • Corporació Sanitària Parc Taulí, Anaesthesiology
    Barcelona, Spain
  • Fundació Puigvert Anaesthesiology
    Barcelona, Spain
  • Hospital Clinic, Anaesthesiology
    Barcelona, Spain
  • Hospital Sant Pau, Anaesthesiology
    Barcelona, Spain
  • Parc de Salut Mar, Anesthesiology
    Barcelona, Spain
  • Vall d'Hebron University Hospital, Anaesthesiology
    Barcelona, Spain
  • Hospital General de La Palma, Anestesiología y Reanimación
    Breña Alta, Spain
  • Hospital de Denia,Anesthesia and Intensive Care
    Denia, Spain
  • Hospital San Jorge, Anaesthesiology
    Huesca, Spain
  • Hospital Arnau de Vilanova Departement of Anesthesiology
    Lleida, Spain
  • Hospital Santa Maria, Departement of Anesthesiology
    Lleida, Spain
  • Hospital 12 Octubre, Anaesthesiology
    Madrid, Spain
  • Hospital del Tajo Anaesthesia and Reanimation
    Madrid, Spain
  • Hospital Universitario de La Princesa, Anesthesiology
    Madrid, Spain
  • Hospital Universitario de Móstoles, anestesiología y Reanimación
    Madrid, Spain
  • Fundacio Althaia, Anaesthesiology
    Manresa, Spain
  • Hospital Son Llatzer, Anaesthesiology
    Palma de Mallorca, Spain
  • Clinica Universidad de Navarra, Anaesthesia
    Pamplona, Spain
  • Hospital Universitario Marques De Valdecilla
    Santander, Spain
  • Virgen del Rocio General Universitary Hospital;Anaesthesiology
    Seville, Spain
  • Consorcio Hospital General Universitario, Anesthesiology, Critical Care and Pain Relief Unit
    Valencia, Spain
  • Hospital Clínic Universitari de València, Anestesiología y Reanimación
    Valencia, Spain
  • Hospital Universitario Rio Hortgea, Anaesthesia and Surgical Critical Care
    Valladolid, Spain
  • Ospedale Regionale di Lugano, Anestesia
    Lugano, Switzerland
  • Medical Faculty of Istanbul, Istanbul University, Anaesthesiology
    Istanbul, Turkey
  • St.Katherine Hospital of Cardiology Anesthesiology & Pain Treatment
    Odessa, Ukraine
09

References and documents

Publications

  • Canet J, Hardman J, Sabate 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. No abstract available. PubMed 21544025 ↗
  • Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate 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. PubMed 21045639 ↗
  • Canet J, Sabate 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. PubMed 26020123 ↗
  • Mazo V, Sabate S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000000334. PubMed 24901240 ↗
  • Russotto V, Sabate S, Canet J; PERISCOPE group; of the European Society of Anaesthesiology (ESA) Clinical Trial Network. Development of a prediction model for postoperative pneumonia: A multicentre prospective observational study. Eur J Anaesthesiol. 2019 Feb;36(2):93-104. doi: 10.1097/EJA.0000000000000921. PubMed 30431500 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2011, a primary completion of Aug 2011 and a completion of Sep 2011. It does not say whether these dates are actual or estimated.

Results were first posted in Apr 2022, 10 years 8 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 20, 2011
First posted
May 3, 2011
Start
May 2011
Primary completionActual
Aug 2011
CompletionActual
Sep 2011
Results first posted
Apr 5, 2022
Last update
Apr 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01346709
Lead sponsor
European Society of Anaesthesiology
Responsible party
Sponsor
First posted
May 3, 2011
Start date
May 2011
Primary completion
Aug 2011
Completion
Sep 2011
Results posted
Apr 5, 2022
Last update
Apr 5, 2022

Study contacts

Jaume Canet, MD
study director · Hospital Universitari Germans Trias I Pujol, Barcelona, Spain
Sergi Sabaté, MD, PhD
principal investigator · Fundació Puigvert (IUNA), Barcelona, Spain
Olivier Langeron, MD, PhD
principal investigator · Groupe Hospitalier Pitie-Salpetriere
Marcelo Gama de Abreu, MD,PhD,DEAA
principal investigator · University Hospital Carl Gustav Carus Dresden University of Technology, Dresden, Germany
Lluís Gallart, MD
principal investigator · Parc de Salut Mar Anaesthesiology Research Group IMIM, Universitat Autònoma de Barcelona, Barcelona, Spain
Francisco Javier Belda, MD
principal investigator · Hospital Clínico Universitario de Valencia, Valencia, Spain
Paolo Pelosi, MD, PhD
principal investigator · University of Genoa, Genoa, Italy - San Martino Hospital, Genoa, Italy
Valentin Mazo, MD
study chair · Hospital Universitari Germans Trias I Pujol, Barcelona, Spain
Andreas Hoeft, MD
principal investigator · University Hospital, Bonn

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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