POPULAR: POst-operative PULmonary Complications After Use of Muscle Relaxants in Europe (POPULAR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01865513|
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : October 14, 2015
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|
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 Type :||Observational|
|Actual Enrollment :||22000 participants|
|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|
- 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
- in-hospital mortality [ Time Frame: up to 28 days after surgery ]
- length of in-hospital stay [ Time Frame: up to 28 days after surgery ]
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
|Klinikum rechts der Isar, Technische Universität München|
|München, Germany, 81675|
|Karolinska Institutet and Karolinska University Hospital|
|Stockholm, Sweden, 171 76|
|Study Chair:||Manfred Blobner, M.D.||Klinikum rechts der Isar Technische Universität München|