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

Anaesthesia Clinical Trial

— POPULAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865513
• Other study ID #: POPULAR
• Status: Completed
• Phase: N/A
• First received: May 28, 2013
• Last updated: October 13, 2015
• Start date: June 2014
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: European Society of Anaesthesiology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22000
• Est. completion date: August 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anaesthesia
• Muscle Hypotonia
• Surgical Procedures, Operative

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar, Technische Universität München	München
Sweden	Karolinska Institutet and Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
European Society of Anaesthesiology

Countries where clinical trial is conducted

Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary study outcome parameter is the rate of post-operative pulmonary Complications (POPC).	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	up to 28 days after surgery	No
Secondary	in-hospital mortality		up to 28 days after surgery	No
Secondary	length of in-hospital stay		up to 28 days after surgery	No

External Links

•   European Society of Anaesthesiology Clinical Trial Network website