Clinical trial NCT01865513: POPULAR: POst-operative PULmonary Complications After Use of Muscle Relaxants in Europe
Official title: POPULAR: POst-operative PULmonary Complications After Use of Muscle Relaxants in Europe - A European Prospective Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Procedures, Operative
Anaesthesia
Keywords: Anaesthesia
Anaesthesiology
muscle Relaxants
POPULAR
postoperative pulmonary complications
Respiratory failure
Suspected pulmonary infection
Pulmonary infiltrates
Pleural effusion
Atelectasis
Pneumothorax
Bronchospasm
Aspiration pneumonitis
Cardiopulmonary oedema
European Society of Anaesthesiology
neuromuscular blockade
europe
Lead sponsor: European Society of Anaesthesiology
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 22000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Patients undergoing any in-hospital surgical procedure under general or regional anaesthesia

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary study outcome parameter is the rate of post-operative pulmonary Complications (POPC).
timeFrame: up to 28 days after surgery
Secondary outcomes:
measure: in-hospital mortality
timeFrame: up to 28 days after surgery
measure: length of in-hospital stay
timeFrame: up to 28 days after surgery
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum rechts der Isar, Technische Universität München
city: Stockholm
country: Sweden
facility: Karolinska Institutet and Karolinska University Hospital
Study officials:
affiliation: Klinikum rechts der Isar Technische Universität München
name: Manfred Blobner, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.