Clinical trial NCT01601223: Local Assessment of Ventilatory Management During General Anesthesia for Surgery
Official title: Local Assessment of Ventilatory Management During General Anesthesia for Surgery - a Prospective Observational Multi-center Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Anaesthesia
Ventilator-Induced Lung Injury
Lung Injury
Pneumonia
Pneumothorax
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Keywords: 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
Lead sponsor: European Society of Anaesthesiology
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2012-05-17
Enrollment: 10690
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: Mechanically ventilated patients undergoing general anesthesia for surgery during a period of one week

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?

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

Primary outcomes:
measure: Post-operative pulmonary complications, possibly related to ventilation strategy
timeFrame: Post-operative on day of surgery, day 1, 2,3,4,5 and day 28
Secondary outcomes:
measure: Intra-operative complications related to the ventilation strategy
timeFrame: Time point(s) at which outcome measure is assessed is is: Day of surgery, day 1, 2, 3, 4, 5 and 28 after surgery
measure: Mechanical ventilation-settings during general anesthesia for surgery
timeFrame: During the surgical procedure, from moment of to tracheal extubation or discharge from operation room (in case patient remains on mechanical ventilation)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine/University of Colorado Hospital
state: Colorado
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Tallinn
country: Estonia
facility: North Estonia Medical Center
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus, Dresden University of Technonology, Department of Anesthesiology and Intensive Care Therapy
city: Duesseldorf
country: Germany
facility: Duesseldorf University Hospital
city: Hannover
country: Germany
facility: Diakoniekrankenhaus Friederikenstift
city: Genoa
country: Italy
facility: Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital - Institute of Oncology
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital - Santariskiu Clinics
city: Amsterdam
country: Netherlands
facility: Academic Medical Center, University of Amsterdam
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Den Haag
country: Netherlands
facility: MC Haaglanden
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Førde
country: Norway
facility: Førde Central Hospital /Førde Sentral Sykehus
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Ljubljana
city: Ljubljana
country: Slovenia
facility: University Medicine Centre Ljubljana
Study officials:
affiliation: AMC, Amsterdam, The Netherlands
name: Schultz Marcus, MD
role: STUDY_CHAIR
affiliation: AMC, Amsterdam, The Netherlands
name: Sabrine Hemmes, MD
role: STUDY_DIRECTOR
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