Popular Study

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Steering Committee

Prof. M. Blobner (Germany), Dr. E. Baumueller (Germany), Prof. L.I. Eriksson (Sweden), Dr. H. Fink (Germany), Prof. M. Hollmann (Netherlands), Prof. J.M. Hunter (United Kingdom), Dr. M. Jonsson Fagerlund (Sweden), Prof. C. Meistelman (France)

Medical Problem

A 4% overall postoperative mortality in patients undergoing non-cardiac surgery in Europe (EUSOS study) suggests there is a need to implement measures to improve postoperative outcome. Because postoperative pulmonary complications (POPC) are a major factor increasing patient morbidity and mortality, the incidence of POPC in Europe is currently under investigation (PERISCOPE study).Residual effects of muscle relaxants, also known as postoperative residual curarization are associated with increased risk for early and late respiratory adverse events after surgery. Residual curarization is seen in approximately 30 % of patients arriving to the postoperative unit or recovery room and show even further increased incidence in patients not receiving adequate neuromuscular monitoring and/or pharmacological reversal. The incidence of postoperative pulmonary complications (POPC) in relation with the management of neuromuscular block during anesthesia is unclear.This prospective, cohort multi-centre observational study is designed to evaluate the impact of the use of muscle relaxants, the monitoring of their action, and reversal agents on the incidence of POPC in an anaesthetized population across Europe. The investigation will be a continuation of the European EUSOS and PERISCOPE studies. We hypothesise that incorrect approaches to the use, monitoring, and reversal of muscle relaxants increase the incidence of in-hospital postoperative pulmonary complications and prolong in-hospital stay.The investigators will not modify a participating centre’s customary management of patients. Patients with POPC will be identified by postoperative assessment and consulting medical records for events that fulfil the definition of POPC.

Objective

POPULAR is designed to evaluate the effects of management of neuromuscular block on postoperative pulmonary complications in a general unrestricted anaesthetized population across Europe.

Study design

Prospective, observational, multi–centre cohort study.

Inclusion Criteria

– Patients undergoing any in-hospital surgical procedure under general anaesthesia during a defined continued 14-day period of recruitment.

Exclusion Criteria

– Patients less than 18 years of age

– Patients scheduled for local or regional anaesthesia only

– Patients’ anaesthetic procedure scheduled outside an operating room

– Ambulatory patients

– Patients planned to be discharged within 12 hours postanaesthesia

– Patients with preoperatively intubated trachea

– Patients from an intensive care unit

– Patients scheduled for additional surgical / anaesthetic procedure in the next 7 days

– Patients who had a surgical / anaesthetic procedure within the past 7 days

Outcomes

Primary endpoint

– The primary study outcome parameter is the rate of POPC, defined as a composite of in-hospital fatal or non-fatal postoperative pulmonary or respiratory events.

Secondary endpoints

– In-hospital mortality

– Length of in-hospital stay

Sample Size and Centres

It is planned to recruit at least 20,000 patients in Europe. Recruitment started in Summer 2014 for a period of at least 9 months.