POPULAR: POst-operative PULmonary Complications After Use of Muscle Relaxants in Europe
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.
Surgical Procedures, Operative
|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|
- 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
- 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 ]
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01865513
|Contact: Brigitte Levafirstname.lastname@example.org|
|Klinikum rechts der Isar, Technische Universität München||Recruiting|
|München, Germany, 81675|
|Contact: Manfred Blobner, MD PhD email@example.com|
|Karolinska Institutet and Karolinska University Hospital||Not yet recruiting|
|Stockholm, Sweden, 171 76|
|Contact: Lars I. Eriksson, MD PhD FRCA firstname.lastname@example.org|
|Principal Investigator: Lars I. Eriksson, MD PhD FRCA|
|Study Chair:||Manfred Blobner, M.D.||Klinikum rechts der Isar, Technische Universität München|