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Automated Control of Mechanical Ventilation During General Anaesthesia

NCT02644005 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-04-18

No results posted yet for this study

Summary

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

Conditions

  • Anesthesia

Interventions

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.

Sponsors & Collaborators

  • Drägerwerk AG & Co. KGaA

    collaborator INDUSTRY

  • University Hospital Schleswig-Holstein

    lead OTHER

Principal Investigators

  • Norbert Weiler, M.D. · University Medical Center Schleswig-Holstein, Campus Kiel, Germany, Department of Anesthesiology and Intensive Care Medicine

  • Christoph Hörmann, M.D. · University Hospital St. Pölten, Austria, Department of Anesthesiology and Intensive Care Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-07
Primary Completion
2019-03-07
Completion
2019-03-07

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02644005 on ClinicalTrials.gov