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

Sponsor

European Society of Anaesthesiology (Other)

Overall Status

Completed

CT.gov ID

NCT01865513

Collaborator

(none)

22,000

Enrollment

Locations

Duration (Months)

11000

Patients Per Site

785.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Procedures, Operative Anaesthesia

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 Design

Study Type:

Observational

Actual Enrollment :

22000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Outcome Measures

Primary Outcome Measures

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

in-hospital mortality [up to 28 days after surgery]
length of in-hospital stay [up to 28 days after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Patients less than 18 years of age
Patients scheduled for local or regional anaesthesia only
Patient's anaesthetic procedure scheduled outside an operating room
Ambulatory patients = Patient planned to be discharged within 12 hours post anaesthesia
Patient with preoperatively intubated trachea
Patient from an intensive care unit (ICU)
Patient scheduled for additional surgical / anaesthetic procedure in the next 7 days
Patients who had a surgical / anaesthetic procedure within the past 7 days
Patient born outside the predetermined 'month(s)' allocated for the specific study centre.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum rechts der Isar, Technische Universität München	München		Germany	81675
2	Karolinska Institutet and Karolinska University Hospital	Stockholm		Sweden	171 76