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AnesthesiaAVASNCT02644005

Automated Control of Mechanical Ventilation During General Anaesthesia

An observational study of Anesthesia, run by University Hospital Schleswig-Holstein at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Anesthesia
Type of treatment
Medical device
How many people
100 participants
Where
2 sitesin 2 countries
Study dates
7 Jul 2017to 7 Mar 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients scheduled for elective surgery in general anesthesia.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Austria1 site

  • University Hospital St. Pölten, Department of Anesthesiology and Intensive Care Medicine

    Sankt Pölten, A-3100

Other trials in Austria

Germany1 site

  • University Medical Center Schleswig-Holstein, Campus Kiel, Department of Anesthesiology and Intensive Care Medicine

    Kiel, 24105

Other trials in Germany

About this study

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

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

Read the 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
Being tested
Smart Vent Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smart Vent ControlDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of adverse events.

    • Severe hypoventilation defined as minute volume lower than 40 ml/kg predicted body weight for longer than 5 minutes
    • Apnea for longer than 90 seconds
    • Hyperventilation defined as PetCO2 lower than 5 mm Hg of the lower target setting for SVC for longer than 5 minutes
    • Hypoventilation defined as PetCO2 higher than 5 mm Hg of the upper target setting for the SVC for longer than 5 minutes
    • Respiratory rate > 35 breaths per minute for longer than 5 minutes
    • Any override or stop of the automated controlled ventilation settings by the anesthesiologist in charge if the settings are clinically not acceptable. Reasons for overriding or stopping the system will be noted.

    Measured: During artificial ventilation with SVC (up to 8 hours).

Secondary outcomes (10)

  1. 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:

    • hypoventilated patient: PaCO2 > (PaCO2_target+5)
    • hyperventilated patient: PaCO2 < (PaCO2_target-5)
    • normoventilated patient: (PaCO2_target-5) ≤ PaCO2 ≤ PaCO2_target+5

    Measured: During artificial ventilation with SVC (up to 8 hours).

  2. Time period between switch from controlled ventilation to augmented ventilation and achievement of stable assisted ventilation of the patient.

    Measured: During artificial ventilation with SVC (up to 8 hours).

  3. Proportion of time within the target zones for tidal volume and PetCO2 as individually set up for each patient by the user.

    Measured: During artificial ventilation with SVC (up to 8 hours).

  4. Frequency of alarms.

    Measured: During artificial ventilation with SVC (up to 8 hours).

  5. Frequency distribution of tidal volume (ml/kg predicted body weight).

    Measured: During artificial ventilation with SVC (up to 8 hours).

  6. Frequency distribution of inspiratory pressure (mbar).

    Measured: During artificial ventilation with SVC (up to 8 hours).

  7. Frequency distribution of inspiration time (s).

    Measured: During artificial ventilation with SVC (up to 8 hours).

  8. Frequency distribution of expiration time (s).

    Measured: During artificial ventilation with SVC (up to 8 hours).

  9. Frequency distribution of PetCO2 (mmHg).

    Measured: During artificial ventilation with SVC (up to 8 hours).

  10. Number of re-intubations.

    Measured: During artificial ventilation with SVC (up to 8 hours).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2015 (estimated)
  2. Study start7 Jul 2017
  3. Primary completion7 Mar 2019
  4. Study completion7 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02644005
Sponsor's protocol ID
AVAS
Acronym
AVAS
Status last verified
Apr 2019
First submitted
11 Dec 2015
Last updated
18 Apr 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28495814

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, run by University Hospital Schleswig-Holstein at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of adverse events. (time frame: During artificial ventilation with SVC (up to 8 hours).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02644005, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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