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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01865513
First Posted: May 31, 2013
Last Update Posted: October 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
European Society of Anaesthesiology
May 28, 2013
May 31, 2013
October 14, 2015
June 2014
April 2015   (Final data collection date for primary outcome measure)
The primary study outcome parameter is the rate of post-operative pulmonary Complications (POPC). [ Time Frame: 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

The primary study outcome parameter is the rate of post-operative pulmonary Complications (POPC). [ Time Frame: up to 28 days after surgery ]

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:

  • Respiratory failure
  • Suspected pulmonary infection
  • Pulmonary infiltrate
  • Pleural effusion
  • Atelectasis
  • Pneumothorax
  • Bronchospasm
  • Aspiration pneumonitis
  • Cardiopulmonary edema
Complete list of historical versions of study NCT01865513 on ClinicalTrials.gov Archive Site
  • in-hospital mortality [ Time Frame: up to 28 days after surgery ]
  • length of in-hospital stay [ Time Frame: up to 28 days after surgery ]
Same as current
Not Provided
Not Provided
 
POPULAR: POst-operative PULmonary Complications After Use of Muscle Relaxants in Europe
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
Adult Patients undergoing any in-hospital surgical procedure under general or regional anaesthesia
  • Surgical Procedures, Operative
  • Anaesthesia
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22000
August 2015
April 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Sweden
 
 
NCT01865513
POPULAR
No
Not Provided
Not Provided
European Society of Anaesthesiology
European Society of Anaesthesiology
Not Provided
Study Chair: Manfred Blobner, M.D. Klinikum rechts der Isar, Technische Universität München
European Society of Anaesthesiology
October 2015