Automated Control of Mechanical Ventilation During General Anaesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-07

Study Completion Date

2019-03-07

Brief Summary

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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.

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Detailed Description

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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

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Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Planned elective surgery of the upper limb, lower limb or peripheral vascular surgery in general anesthesia
* Patient is classified as American Society of Anesthesiologists physical status (ASA) I, II or III
* Age ≥ 18 years
* Written consent of the patient for study participation

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

* Mild, moderate or severe ARDS
* Hemodynamic instability: systolic blood pressure \< 90 mm Hg, mean arterial pressure \< 70 mm Hg or administration of any vasoactive drugs.
* Acute renal failure: oliguria (urine output \< 0.5 ml/kg/h for at least 2 hours despite of adequate management or creatinine increase \> 0.5 mg/dl
* Cerebral failure: loose of consciousness or encephalopathy
* Patient is pregnant.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No