Local Assessment of Ventilatory Management During General Anesthesia for Surgery

Completed

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

• Registration Number: NCT01601223
• Lead Sponsor: European Society of Anaesthesiology

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?

Study Timeline

• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-17
• Study Start: 2013-01
• Primary Completion: 2013-05
• Study Completion: 2013-11
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10690

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative pulmonary complications, possibly related to ventilation strategy	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 Outcome Measures

Name	Time	Method
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)	* Variation of applied MV settings within centers; * Variation of applied MV settings between centers on an international basis
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

Trial Locations

Locations (19)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Colorado School of Medicine/University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

University Hospital Carl Gustav Carus, Dresden University of Technonology, Department of Anesthesiology and Intensive Care Therapy; 🇩🇪 Dresden, Germany

Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate; 🇮🇹 Genoa, Italy

Diakoniekrankenhaus Friederikenstift; 🇩🇪 Hannover, Germany

Ospedale San Raffaele; 🇮🇹 Milano, Italy

Vilnius University Hospital - Santariskiu Clinics; 🇱🇹 Vilnius, Lithuania

VU University Medical Center; 🇳🇱 Amsterdam, Netherlands

MC Haaglanden; 🇳🇱 Den Haag, Netherlands

Førde Central Hospital /Førde Sentral Sykehus; 🇳🇴 Førde, Norway

Institute of Oncology Ljubljana; 🇸🇮 Ljubljana, Slovenia

North Estonia Medical Center; 🇪🇪 Tallinn, Estonia

Tartu University Hospital; 🇪🇪 Tartu, Estonia

Vilnius University Hospital - Institute of Oncology; 🇱🇹 Vilnius, Lithuania

Academic Medical Center, University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

Haukeland University Hospital; 🇳🇴 Bergen, Norway

University Medicine Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia

Duesseldorf University Hospital; 🇩🇪 Duesseldorf, Germany