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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by European Society of Anaesthesiology
Sponsor:
Information provided by (Responsible Party):
European Society of Anaesthesiology
ClinicalTrials.gov Identifier:
NCT01865513
First received: May 28, 2013
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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
Surgical Procedures, Operative
Anaesthesia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by European Society of Anaesthesiology:

Primary Outcome Measures:
  • The primary study outcome parameter is the rate of post-operative pulmonary Complications (POPC). [ Time Frame: up to 28 days after surgery ] [ Designated as safety issue: No ]

    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:
  • in-hospital mortality [ Time Frame: up to 28 days after surgery ] [ Designated as safety issue: No ]
  • length of in-hospital stay [ Time Frame: up to 28 days after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 24000
Study Start Date: June 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865513

Contacts
Contact: Brigitte Leva research@esahq.org

Locations
Germany
Klinikum rechts der Isar, Technische Universität München Recruiting
München, Germany, 81675
Contact: Manfred Blobner, MD PhD       blobner@lrz.tu-muenchen.de   
Sweden
Karolinska Institutet and Karolinska University Hospital Not yet recruiting
Stockholm, Sweden, 171 76
Contact: Lars I. Eriksson, MD PhD FRCA       lars.i.eriksson@karolinska.se   
Principal Investigator: Lars I. Eriksson, MD PhD FRCA         
Sponsors and Collaborators
European Society of Anaesthesiology
Investigators
Study Chair: Manfred Blobner, M.D. Klinikum rechts der Isar, Technische Universität München
  More Information

Additional Information:
No publications provided

Responsible Party: European Society of Anaesthesiology
ClinicalTrials.gov Identifier: NCT01865513     History of Changes
Other Study ID Numbers: POPULAR
Study First Received: May 28, 2013
Last Updated: August 12, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by European Society of Anaesthesiology:
Aspiration pneumonitis
Anaesthesia
Anaesthesiology
muscle Relaxants
POPULAR
postoperative pulmonary complications
Respiratory failure
Suspected pulmonary infection
Pulmonary infiltrates
Pleural effusion
Atelectasis
Pneumothorax
Bronchospasm
Cardiopulmonary oedema
European Society of Anaesthesiology
neuromuscular blockade
europe

Additional relevant MeSH terms:
Muscle Hypotonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014