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

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

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.

Study Overview

• Status: Completed
• Conditions: Anaesthesia; Surgical Procedures, Operative

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 Type: Observational
• Enrollment (Actual): 22000

Contacts and Locations

Study Locations

• Germany
  • München, Germany, 81675
    • Klinikum rechts der Isar, Technische Universität München
• Sweden
  • Stockholm, Sweden, 171 76
    • Karolinska Institutet and Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult Patients undergoing any in-hospital surgical procedure under general or regional anaesthesia

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
in-hospital mortality	up to 28 days after surgery
length of in-hospital stay	up to 28 days after surgery

Collaborators and Investigators

• Sponsor: European Society of Anaesthesiology
• Investigators: Study Chair: Manfred Blobner, M.D., Klinikum rechts der Isar Technische Universität München

Publications and helpful links

General Publications

• Blobner M, Hunter JM, Meistelman C, Hoeft A, Hollmann MW, Kirmeier E, Lewald H, Ulm K. Use of a train-of-four ratio of 0.95 versus 0.9 for tracheal extubation: an exploratory analysis of POPULAR data. Br J Anaesth. 2020 Jan;124(1):63-72. doi: 10.1016/j.bja.2019.08.023. Epub 2019 Oct 10.
• Kirmeier E, Eriksson LI, Lewald H, Jonsson Fagerlund M, Hoeft A, Hollmann M, Meistelman C, Hunter JM, Ulm K, Blobner M; POPULAR Contributors. Post-anaesthesia pulmonary complications after use of muscle relaxants (POPULAR): a multicentre, prospective observational study. Lancet Respir Med. 2019 Feb;7(2):129-140. doi: 10.1016/S2213-2600(18)30294-7. Epub 2018 Sep 14. Erratum In: Lancet Respir Med. 2018 Nov 6;:

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: May 28, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Estimate): October 14, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Anaesthesia; Respiratory failure; Pleural effusion; Atelectasis; neuromuscular blockade; Suspected pulmonary infection; Pneumothorax; Bronchospasm; Anaesthesiology; postoperative pulmonary complications; European Society of Anaesthesiology; Pulmonary infiltrates; muscle Relaxants; POPULAR; Aspiration pneumonitis; Cardiopulmonary oedema; europe
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Muscle Hypotonia
• Other Study ID Numbers: POPULAR