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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:

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.


Sponsor: European Society of Anaesthesiology

Current Primary Outcome: 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



Original Primary Outcome: 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


Current Secondary Outcome:

  • in-hospital mortality [ Time Frame: up to 28 days after surgery ]
  • length of in-hospital stay [ Time Frame: up to 28 days after surgery ]


Original Secondary Outcome: Same as current

Information By: European Society of Anaesthesiology

Dates:
Date Received: May 28, 2013
Date Started: June 2014
Date Completion:
Last Updated: October 13, 2015
Last Verified: October 2015