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Surgical Procedures, OperativePOPULARNCT01865513

POPULAR: POst-operative PULmonary Complications After Use of Muscle Relaxants in Europe

An observational study of Surgical Procedures, Operative and Anaesthesia, run by European Society of Anaesthesiology at 2 sites in 2 countries.

Completed

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

Official record
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Trial summary

International multicenter observational study of a random-sample cohort of patients undergoing any in-hospital surgical procedure under general or regional anaesthesia during a continued 14-day period of recruitment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgical Procedures, Operative, Anaesthesia
How many people
22,000 participants
Where
2 sitesin 2 countries
Study dates
Jun 2014to Aug 2015
Phase
Observational
Are there results?
None posted in the registry

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: Adult Patients undergoing any in-hospital surgical procedure under general or regional anaesthesia

Who may be able to join

  • Adult Patients undergoing any in-hospital surgical procedure under general or regional anaesthesia during the defined continued 14-day period of recruitment.

Who cannot join

  • Patients less than 18 years of age
  • Patients scheduled for local or regional anaesthesia only
  • Patient's anaesthetic procedure scheduled outside an operating room
  • Ambulatory patients = Patient planned to be discharged within 12 hours post anaesthesia
  • Patient with preoperatively intubated trachea
  • Patient from an intensive care unit (ICU)
Show all 9Show fewer
  • Patient scheduled for additional surgical / anaesthetic procedure in the next 7 days
  • Patients who had a surgical / anaesthetic procedure within the past 7 days
  • Patient born outside the predetermined 'month(s)' allocated for the specific study centre.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Germany1 site

  • Klinikum rechts der Isar, Technische Universität München

    München, 81675

Other trials in Germany

Sweden1 site

  • Karolinska Institutet and Karolinska University Hospital

    Stockholm, 171 76

Other trials in Sweden

About this study

Official title: POPULAR: POst-operative PULmonary Complications After Use of Muscle Relaxants in Europe - A European Prospective Multicenter Observational Study

International multicenter observational study of a random-sample cohort of patients undergoing any in-hospital surgical procedure under general or regional anaesthesia during a continued 14-day period of recruitment.

Primary hypothesis of this study is that the use of muscle relaxants, their reversal agents, or neuromuscular monitoring increases the incidence of postoperative pulmonary complications. The secondary hypothesis is that the use of muscle relaxants increases in-hospital mortality.

Read the detailed description

Overall postoperative mortality for patients undergoing non-cardiac surgery in Europe is 4% (EUSOS study). Postoperative pulmonary complications are a major factor, which increase patient morbidity and mortality (PERISCOPE study). This study is designed to evaluate the effects of management of neuromuscular blockade on postoperative pulmonary complications in a general unrestricted anaesthetized population across Europe. The investigation will be a continuation of the European EUSOS and PERISCOPE studies. Based on a well-recognised body of surrogate data, it is hypothesized that incorrect approaches to the use, monitoring, and reversal of muscle relaxants will increase the incidence of in-hospital postoperative pulmonary complications and prolong hospital stay.

The investigators will not modify a participating centre's customary management of patients. Patients with postoperative pulmonary complications will be identified by postoperative assessment and consulting medical records for events that fulfil the definition of postoperative pulmonary complications.

Keywords
Anaesthesia, Anaesthesiology, muscle Relaxants, POPULAR, postoperative pulmonary complications, Respiratory failure, Suspected pulmonary infection, Pulmonary infiltrates, Pleural effusion, Atelectasis, Pneumothorax, Bronchospasm, Aspiration pneumonitis, Cardiopulmonary oedema, European Society of Anaesthesiology, neuromuscular blockade, europe
Medical subject headings
Muscle Hypotonia, Respiratory Insufficiency, Pleural Effusion, Pulmonary Atelectasis, Pneumothorax, Bronchial Spasm, Pneumonia, Aspiration

What is being measured

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

  1. The primary study outcome parameter is the rate of post-operative pulmonary Complications (POPC).

    Post-operative pulmonary Complications (POPC) is a composite of in-hospital fatal or non-fatal postoperative pulmonary events. A patient is assumed to have POPC if at least one of the following complications is documented:

    POPC is defined as a composite of in-hospital fatal or non-fatal postoperative pulmonary or respiratory events:

    Respiratory failure Suspected pulmonary infection, i.e. Suspected pulmonary infiltrates Atelectasis Aspiration pneumonitis Bronchospasm Pulmonary Oedema

    Measured: up to 28 days after surgery

Secondary outcomes (2)

  1. in-hospital mortality

    Measured: up to 28 days after surgery

  2. length of in-hospital stay

    Measured: up to 28 days after surgery

Timeline

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

  1. First posted31 May 2013 (estimated)
  2. Study startJun 2014
  3. Primary completionApr 2015
  4. Study completionAug 2015

Resources

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
22,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01865513
Sponsor's protocol ID
POPULAR
Acronym
POPULAR
Status last verified
Oct 2015
First submitted
28 May 2013
Last updated
14 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Blobner M, Hunter JM, Meistelman C, Hoeft A, Hollmann MW, Kirmeier E, Lewald H, Ulm K. Use of a train-of-four ratio of 0.95 versus 0.9 for tracheal extubation: an exploratory analysis of POPULAR data. Br J Anaesth. 2020 Jan;124(1):63-72. doi: 10.1016/j.bja.2019.08.023. Epub 2019 Oct 10.

    PubMed 31607388

  • Kirmeier E, Eriksson LI, Lewald H, Jonsson Fagerlund M, Hoeft A, Hollmann M, Meistelman C, Hunter JM, Ulm K, Blobner M; POPULAR Contributors. Post-anaesthesia pulmonary complications after use of muscle relaxants (POPULAR): a multicentre, prospective observational study. Lancet Respir Med. 2019 Feb;7(2):129-140. doi: 10.1016/S2213-2600(18)30294-7. Epub 2018 Sep 14.

    PubMed 30224322

Questions about this trial

What is this clinical trial studying?

An observational study of Surgical Procedures, Operative and Anaesthesia, run by European Society of Anaesthesiology at 2 sites in 2 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 9 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 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, Sweden. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 primary study outcome parameter is the rate of post-operative pulmonary Complications (POPC). (time frame: up to 28 days after surgery). 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 NCT01865513, which also lists 2 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 14 Oct 2015.

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