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

Completed

• Conditions: Surgical Procedures, Operative; Anaesthesia

• Registration Number: NCT01865513
• Lead Sponsor: European Society of Anaesthesiology

Brief 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.

Study Timeline

• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-05-31
• Study Start: 2014-06
• Primary Completion: 2015-04
• Study Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary study outcome parameter is the rate of post-operative pulmonary Complications (POPC).	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

Secondary Outcome Measures

Name	Time	Method
in-hospital mortality	up to 28 days after surgery
length of in-hospital stay	up to 28 days after surgery

Trial Locations

Locations (2)

Karolinska Institutet and Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Klinikum rechts der Isar, Technische Universität München; 🇩🇪 München, Germany