NCT02644005

Automated Control of Mechanical Ventilation During General Anaesthesia

Automated Control of Mechanical Ventilation During General Anaesthesia - A Bicentric Prospective Observational Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, bicentric observational study to assess a novel system for automated control of mechanical ventilation (Smart Vent Control, SVC) during general anesthesia.

Detailed description

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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DEVICE	Smart Vent Control	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.

Timeline

• Start date: 2017-07-07
• Primary completion: 2019-03-07
• Completion: 2019-03-07
• First posted: 2015-12-31
• Last updated: 2019-04-18

Locations

2 sites across 2 countries: Austria, Germany