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Clinical Trials/NCT01601223
NCT01601223
Completed
Not Applicable

Local Assessment of Ventilatory Management During General Anesthesia for Surgery - a Prospective Observational Multi-center Cohort Study

European Society of Anaesthesiology19 sites in 8 countries10,690 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
European Society of Anaesthesiology
Enrollment
10690
Locations
19
Primary Endpoint
Post-operative pulmonary complications, possibly related to ventilation strategy
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Objectives

  1. To characterize mechanical ventilation practices during general anesthesia for surgery
  2. To assess the dependence of intra-operative and post-operative pulmonary complications on intra-operative Mechanical Ventilation (MV) settings

Detailed Description

Research questions * What MV-settings are used during general anesthesia for surgery? * Do MV-settings vary in and/or between centers? * Do MV-settings vary internationally? * Are MV-settings associated with incidence of intra-operative pulmonary complications? * Are MV-settings associated with incidence of post-operative pulmonary complications?

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
November 2013
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
European Society of Anaesthesiology
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years
  • All surgical procedures requiring invasive mechanical ventilation (MV)during general anesthesia for laparoscopic or non-laparoscopic surgery.
  • This includes MV performed with supra-glottic devices (e.g. laryngeal mask)
  • This includes patients receiving MV at the onset of the procedure (e.g. Intensive Care Unit patients)
  • This includes patients who will receive one-lung ventilation during the procedure

Exclusion Criteria

  • Obstetric surgical procedures or any procedure during pregnancy
  • Surgical procedures outside the operating room
  • Surgical procedures involving extra-corporal circulation

Outcomes

Primary Outcomes

Post-operative pulmonary complications, possibly related to ventilation strategy

Time Frame: Post-operative on day of surgery, day 1, 2,3,4,5 and day 28

Effect of Mechanical Ventilation settings during general anesthesia for surgery on the incidence of post-operative pulmonary complications (new or prolonged invasive or non-invasive mechanical ventilation, need for oxygen therapy, respiratory failure, pneumonia, ARDS 'Acute Respiratory Distress Syndrome', pneumothorax) Defined post-operative pulmonary complications are recorded from the medical chart on day 0, 1, 2, 3, 4 and 5 after surgery. On day 28 length of hospital stay and in hospital death are assessed.

Secondary Outcomes

  • Mechanical ventilation-settings during general anesthesia for surgery(During the surgical procedure, from moment of to tracheal extubation or discharge from operation room (in case patient remains on mechanical ventilation))
  • Intra-operative complications related to the ventilation strategy(Time point(s) at which outcome measure is assessed is is: Day of surgery, day 1, 2, 3, 4, 5 and 28 after surgery)

Study Sites (19)

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