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| Name | Class |
|---|---|
| Drägerwerk AG & Co. KGaA | INDUSTRY |
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Prospective, bicentric observational study to assess a novel system for automated control of mechanical ventilation (Smart Vent Control, SVC) during general anesthesia.
The "Automated control of mechanical ventilation during general anesthesia study (AVAS study) is an international investigator-initiated bicentric observational study investigating the application of Smart Vent Control (SVC) during general anesthesia. The main objective of this study is to describe the application of SVC and to assess its safety and efficacy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart Vent Control | Device | Smart Vent Control (SVC) was designed to automatically control the following ventilator settings: mechanical breathing frequency, inspiratory pressure, pressure support, inspiratory time, trigger sensitivity. SVC adjusts the ventilator settings with the aim to keep a patient stable in a target zone (TZ). Numerous predefined TZs exist that can be set according to the current therapeutic situation. All TZs are adoptable by the user for each individual patient and consist of upper and lower limits for tidal volume and for the partial pressure of end-tidal carbon dioxide (PetCO2). Based on these limits, the system classifies the current quality of ventilation, called Classification of Ventilation, and derives new ventilator settings accordingly. SVC is available as a software option on Zeus Infinity Empowered anesthesia machines (Drägerwerk AG & Co. KGAa, Lübeck, Germany) and is approved as a medical product according to 93/42/European Economic Community. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events. |
| During artificial ventilation with SVC (up to 8 hours). |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of normoventilated, hypoventilated and hyperventilated patients. | The responsible anesthesiologist defines a target range for the arterial partial pressure of carbon dioxide (PaCO2_target) before the induction of the general anesthesia and sets up the corresponding endtidal CO2-range in the automated ventilation system. 15 minutes after the begin of the surgical procedure an arterial blood gas analysis will be performed and the PaCO2 will be measured. Then patients will be classified as follows:
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Inclusion Criteria:
Exclusion Criteria:
Mild, moderate or severe acute respiratory distress syndrome (ARDS)[10]
Known chronic obstructive pulmonary disease Gold stage III or higher
Two or more of the following organ failures
Patient is pregnant.
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Adult patients scheduled for elective surgery in general anesthesia.
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| Name | Affiliation | Role |
|---|---|---|
| Norbert Weiler, M.D. | University Medical Center Schleswig-Holstein, Campus Kiel, Germany, Department of Anesthesiology and Intensive Care Medicine | Principal Investigator |
| Christoph Hörmann, M.D. | University Hospital St. Pölten, Austria, Department of Anesthesiology and Intensive Care Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital St. Pölten, Department of Anesthesiology and Intensive Care Medicine | Sankt Pölten | A-3100 | Austria | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28495814 | Background | Schadler D, Miestinger G, Becher T, Frerichs I, Weiler N, Hormann C. Automated control of mechanical ventilation during general anaesthesia: study protocol of a bicentric observational study (AVAS). BMJ Open. 2017 May 10;7(5):e014742. doi: 10.1136/bmjopen-2016-014742. |
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| During artificial ventilation with SVC (up to 8 hours). |
| Time period between switch from controlled ventilation to augmented ventilation and achievement of stable assisted ventilation of the patient. | During artificial ventilation with SVC (up to 8 hours). |
| Proportion of time within the target zones for tidal volume and PetCO2 as individually set up for each patient by the user. | During artificial ventilation with SVC (up to 8 hours). |
| Frequency of alarms. | During artificial ventilation with SVC (up to 8 hours). |
| Frequency distribution of tidal volume (ml/kg predicted body weight). | During artificial ventilation with SVC (up to 8 hours). |
| Frequency distribution of inspiratory pressure (mbar). | During artificial ventilation with SVC (up to 8 hours). |
| Frequency distribution of inspiration time (s). | During artificial ventilation with SVC (up to 8 hours). |
| Frequency distribution of expiration time (s). | During artificial ventilation with SVC (up to 8 hours). |
| Frequency distribution of PetCO2 (mmHg). | During artificial ventilation with SVC (up to 8 hours). |
| Number of re-intubations. | During artificial ventilation with SVC (up to 8 hours). |
| University Medical Center Schleswig-Holstein, Campus Kiel, Department of Anesthesiology and Intensive Care Medicine |
| Kiel |
| 24105 |
| Germany |