NCT01865513

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22,000 (actual)
• Sponsor: European Society of Anaesthesiology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Surgical Procedures, Operative
• Anaesthesia

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-04-01
• Completion: 2015-08-01
• First posted: 2013-05-31
• Last updated: 2015-10-14

Locations

2 sites across 2 countries: Germany, Sweden