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

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ClinicalTrials.gov Identifier: NCT01865513
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
European Society of Anaesthesiology

Study Description
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Brief 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.

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.


Condition or disease
Surgical Procedures, Operative Anaesthesia

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.

Study Design
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Study Type : Observational
Actual Enrollment : 22000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: POPULAR: POst-operative PULmonary Complications After Use of Muscle Relaxants in Europe - A European Prospective Multicenter Observational Study
Study Start Date : June 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : August 2015
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. The primary study outcome parameter is the rate of post-operative pulmonary Complications (POPC). [ Time Frame: up to 28 days after surgery ]

    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



Secondary Outcome Measures :
  1. in-hospital mortality [ Time Frame: up to 28 days after surgery ]
  2. length of in-hospital stay [ Time Frame: up to 28 days after surgery ]

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:   Non-Probability Sample
Study Population
Adult Patients undergoing any in-hospital surgical procedure under general or regional anaesthesia
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients less than 18 years of age
  2. Patients scheduled for local or regional anaesthesia only
  3. Patient's anaesthetic procedure scheduled outside an operating room
  4. Ambulatory patients = Patient planned to be discharged within 12 hours post anaesthesia
  5. Patient with preoperatively intubated trachea
  6. Patient from an intensive care unit (ICU)
  7. Patient scheduled for additional surgical / anaesthetic procedure in the next 7 days
  8. Patients who had a surgical / anaesthetic procedure within the past 7 days
  9. Patient born outside the predetermined 'month(s)' allocated for the specific study centre.
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): NCT01865513


Locations
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Germany
Klinikum rechts der Isar, Technische Universität München
München, Germany, 81675
Sweden
Karolinska Institutet and Karolinska University Hospital
Stockholm, Sweden, 171 76
Sponsors and Collaborators
European Society of Anaesthesiology
Investigators
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Study Chair: Manfred Blobner, M.D. Klinikum rechts der Isar Technische Universität München
More Information
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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: NCT01865513    
Other Study ID Numbers: POPULAR
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Keywords provided by European Society of Anaesthesiology:
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
Additional relevant MeSH terms:
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Muscle Hypotonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases