Complication of Surgical ProcedurePERISCOPENCT01346709

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

An observational study of Complication of Surgical Procedure and Acute Respiratory Failure, Adult, run by European Society of Anaesthesiology at 63 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Complication of Surgical Procedure, Acute Respiratory Failure, Adult, Postoperative Respiratory Complications
How many people: 5,450 participants
Where: 63 sitesin 21 countries
Study dates: May 2011to Sep 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: In-patient adult non-obstetric surgery

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

63 sites in 21 countries.

Country

City, postcode or hospital

63 sites in 21 countries

Spain25 sites

Hospital General Universitario Alicante, Anaesthesiology
Alicante
Hospital Universitari Germans Trias i Pujol, Anaesthesiology
Badalona
Corporació Sanitària Parc Taulí, Anaesthesiology
Barcelona
Fundació Puigvert Anaesthesiology
Barcelona
Hospital Clinic, Anaesthesiology
Barcelona
Hospital Sant Pau, Anaesthesiology
Barcelona
Parc de Salut Mar, Anesthesiology
Barcelona
Vall d'Hebron University Hospital, Anaesthesiology
Barcelona
Hospital General de La Palma, Anestesiología y Reanimación
Breña Alta
Hospital de Denia,Anesthesia and Intensive Care
Denia
Hospital San Jorge, Anaesthesiology
Huesca
Hospital Arnau de Vilanova Departement of Anesthesiology
Lleida
Hospital Santa Maria, Departement of Anesthesiology
Lleida
Hospital 12 Octubre, Anaesthesiology
Madrid
Hospital del Tajo Anaesthesia and Reanimation
Madrid
Hospital Universitario de La Princesa, Anesthesiology
Madrid
Hospital Universitario de Móstoles, anestesiología y Reanimación
Madrid
Fundacio Althaia, Anaesthesiology
Manresa
Hospital Son Llatzer, Anaesthesiology
Palma de Mallorca
Clinica Universidad de Navarra, Anaesthesia
Pamplona
Hospital Universitario Marques De Valdecilla
Santander
Virgen del Rocio General Universitary Hospital;Anaesthesiology
Seville
Consorcio Hospital General Universitario, Anesthesiology, Critical Care and Pain Relief Unit
Valencia
Hospital Clínic Universitari de València, Anestesiología y Reanimación
Valencia
Hospital Universitario Rio Hortgea, Anaesthesia and Surgical Critical Care
Valladolid

Other trials in Spain

Italy8 sites

S.Orsola-Malpighi
Bologna
Azienda Ospedaliera S. Croce e Carle, Anesthesia
Cuneo
Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate
Genoa
European Institute of Oncology,Anaesthesia and Intensive Care
Milan
University of Milano, Ospedale San Paolo Dpt Of Anaesthesia and Intensive Care
Milan
Azienda Ospedaliera Padova, Anesthesia and Intensive Care Clinic, Department of Pharmacology and Anesthesiology
Padova
Azienda USL n. 5 di Pisa Ospedale F. Lotti Anestesia e Rianimazione
Pontedera
University Of Insubria
Varese

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Germany4 sites

University Hospital Bonn, Anesthesiology
Bonn
Klinikum Darmstadt GmbH Anesthesiology, Intensive Care and pain medicin
Darmstadt
University Hospital Carl Gustav Carus, Dresden University of Technonology, Department of Anesthesiology and Intensive Care Therapy
Dresden
Universitätsmedizin Mainz, Departement of Anesthesiology
Mainz

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Portugal4 sites

Hospitais da Universidade de Coimbra, EPE. Departement of Anesthesiology
Coimbra
Centro Hospitalar de Lisboa Ocidental, Serviço de Anestesia
Lisbon
Hospital Fernando Fonseca,Anesthesiology
Lisbon
Instituto Português de Oncologia, Departement of Anesthesiology
Porto

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Romania3 sites

Emergency Institute of Cardiovascular Diseases Prof Dr C. C. Iliescu, Cardiac Anesthesia and Intensive Care
Bucharest
Emergency Clinical Hospital of Constanta, Department of Anaesthesiology and Intensive Care
Constanța
Emergency County Hospital Clinic of Anesthesia and Intensive Care, Intensive Care and Anesthesiology
Târgu Mureş

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Bosnia and Herzegovina2 sites

General Hospital "Prim.dr Abdulah Nakas" Departement of Anaesthesia and intensive care
Sarajevo
Heart Center
Sarajevo

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Czechia2 sites

Faculty Hospital Brno, department of Anaesthesiology and Intensive Care Medicine
Brno
Masaryks hospital Usti nad labem, Dept. of Anesthesia and intensive medicine
Ústí nad Labem

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Lithuania2 sites

Hospital of Lithuanian University of Health Sciences, Clinic of Anaesthesiology
Kaunas
Vilnius University Hospital Santariskiu Clinics, Center of Anesthesiology, Intensive Care and Pain Treatment
Vilnius

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Albania1 site

University Hospital centre "Mother Theresa" Anesthesia & critical Care
Tirana

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Belgium1 site

Cliniques Universitaires Saint Luc
Brussels, 1200

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Croatia1 site

University Hospital Rijeka Anaesthesiology and Intensive care
Rijeka

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Estonia1 site

Tartu University Hospital Clinic of Anaesthesiology and Intensive Care
Tartu

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France1 site

Hôpital Pitié-Salpêtrière, Anesthesiology and Critical Care
Paris

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Hungary1 site

MISEK Kft., Anaesthesiology and Intensive Care Unit
Miskolc

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Latvia1 site

P Stradins Clinical University hospital, Departement of Anesthesiology
Riga

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Luxembourg1 site

ZithaKlinik, Anaesthesiology and Intensive Care
Luxembourg

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Poland1 site

10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy, Anaesthesiology and Intensive Care
Bydgoszcz

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Russia1 site

Krasnoyarsk State Medical University,Anesthesiology and Intensive Care
Krasnoyarsk

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Switzerland1 site

Ospedale Regionale di Lugano, Anestesia
Lugano

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Turkey (Türkiye)1 site

Medical Faculty of Istanbul, Istanbul University, Anaesthesiology
Istanbul

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Ukraine1 site

St.Katherine Hospital of Cardiology Anesthesiology & Pain Treatment
Odesa

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About this study

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

Read the detailed description

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.

Conditions: 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
Medical subject headings: Respiratory Insufficiency, Acute Lung Injury, Respiratory Distress Syndrome, Pleural Effusion, Pulmonary Atelectasis, Pneumothorax, Bronchial Spasm, Pneumonia, Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01346709
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Postoperative in-hospital stay up to 5 weeks

Secondary outcomes (2)

a) Postoperative Length of Stay
Participants will be followed for the duration of in-hospital stay up to 90 days
Measured: Postoperative in-hospital stay up to 90 days
b) In-hospital Mortality
Participants will be followed for the duration of in-hospital stay up to 90 days
Measured: Postoperative in-hospital stay up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Sep 2011

First posted3 May 2011 (estimated)
Study startMay 2011
Primary completionAug 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Complication of Surgical ProcedureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 5,450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01346709
Sponsor's protocol ID: PERISCOPE
Acronym: PERISCOPE
Status last verified: Oct 2015
First submitted: 20 Apr 2011
Last updated: 5 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01346709
Acronym / sponsor ID: PERISCOPE / PERISCOPE
Conditions: 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
Study type: Observational
Recruitment status: Completed
Enrolment: 5,450 participants (actual)
Lead sponsor: European Society of AnaesthesiologyUniversity, hospital or other
Study start: May 2011
Primary completion: Aug 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 3 May 2011 (estimated)
Results: Posted 5 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

TIMEFRAME Participants will be followed for the duration of in-hospital stay, an expected average of maximum 5 weeks.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: In-patient adult non-obstetric surgery

Key inclusion criteria (1 listed)

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).

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

2 secondary outcomes

a) Postoperative Length of Stay
Time frame: Postoperative in-hospital stay up to 90 days
b) In-hospital Mortality
Time frame: Postoperative in-hospital stay up to 90 days

Results and safety

Results posted to the registry on 5 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
In-patient Adult Non-obstetricSurgical	5,450	5,099

Primary outcome: 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. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	In-patient Adult Non-obstetricSurgical n = 5099
Value	7.92 (7.20 to 8.70)

Population analysed: PPC incidence, Percentage in Patients valid for external validation study

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Observational Study Section Not Applicable	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21544025Canet 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.
Background: PubMed 21045639Canet 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.
Results publication: PubMed 26020123Canet 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.
Results publication: PubMed 24901240Mazo 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.
Derived from this study: PubMed 30431500Russotto 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.
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 linkLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

63 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Complication of Surgical Procedure and Acute Respiratory Failure, Adult, run by European Society of Anaesthesiology at 63 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in Spain, Italy, Germany, Portugal, Romania and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01346709, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.