Local Assessment of Ventilatory Management During General Anesthesia for Surgery

Study Overview
=================
Brief Summary
-----------------
Objectives To characterize mechanical ventilation practices during general anesthesia for surgery 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?

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

Conditions
-----------------
Surgery, Anaesthesia, Ventilator-Induced Lung Injury, Lung Injury, Pneumonia, Pneumothorax, Respiratory Distress Syndrome, Adult, Respiratory Insufficiency

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical mechanically-ventilated<br>Surgical patients undergoing invasive mechanical ventilation for general anesthesia | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pulmonary complications, possibly related to ventilation strategy | 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. | Post-operative on day of surgery, day 1, 2,3,4,5 and day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Mechanical ventilation-settings during general anesthesia for surgery | Variation of applied MV settings within centers Variation of applied MV settings between centers on an international basis | During the surgical procedure, from moment of to tracheal extubation or discharge from operation room (in case patient remains on mechanical ventilation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventilatory Management, Mechanical Ventilation, Post Operative pulmonary complications, Intra-operative complications, General Anesthesia, Surgery, LAS VEGAS, ESA (European Society of Anaesthesiology), European Society of Anaesthesiology