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Automated Control of Mechanical Ventilation During General Anaesthesia (AVAS)

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ClinicalTrials.gov Identifier: NCT02644005
Recruitment Status : Completed
First Posted : December 31, 2015
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
Drägerwerk AG & Co. KGaA
Information provided by (Responsible Party):
Norbert Weiler, University of Schleswig-Holstein

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

Condition or disease Intervention/treatment
Anesthesia Device: Smart Vent Control

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Automated Control of Mechanical Ventilation During General Anaesthesia - A Bicentric Prospective Observational Trial
Actual Study Start Date : July 7, 2017
Actual Primary Completion Date : March 7, 2019
Actual Study Completion Date : March 7, 2019

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Frequency of adverse events. [ Time Frame: During artificial ventilation with SVC (up to 8 hours). ]
    • 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.


Secondary Outcome Measures :
  1. Frequency of normoventilated, hypoventilated and hyperventilated patients. [ Time Frame: During artificial ventilation with SVC (up to 8 hours). ]

    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

  2. Time period between switch from controlled ventilation to augmented ventilation and achievement of stable assisted ventilation of the patient. [ Time Frame: 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. [ Time Frame: During artificial ventilation with SVC (up to 8 hours). ]
  4. Frequency of alarms. [ Time Frame: During artificial ventilation with SVC (up to 8 hours). ]
  5. Frequency distribution of tidal volume (ml/kg predicted body weight). [ Time Frame: During artificial ventilation with SVC (up to 8 hours). ]
  6. Frequency distribution of inspiratory pressure (mbar). [ Time Frame: During artificial ventilation with SVC (up to 8 hours). ]
  7. Frequency distribution of inspiration time (s). [ Time Frame: During artificial ventilation with SVC (up to 8 hours). ]
  8. Frequency distribution of expiration time (s). [ Time Frame: During artificial ventilation with SVC (up to 8 hours). ]
  9. Frequency distribution of PetCO2 (mmHg). [ Time Frame: During artificial ventilation with SVC (up to 8 hours). ]
  10. Number of re-intubations. [ Time Frame: During artificial ventilation with SVC (up to 8 hours). ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients scheduled for elective surgery in general anesthesia.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644005


Locations
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Austria
University Hospital St. Pölten, Department of Anesthesiology and Intensive Care Medicine
St. Pölten, Austria, A-3100
Germany
University Medical Center Schleswig-Holstein, Campus Kiel, Department of Anesthesiology and Intensive Care Medicine
Kiel, Germany, 24105
Sponsors and Collaborators
University of Schleswig-Holstein
Drägerwerk AG & Co. KGaA
Investigators
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Principal Investigator: 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

Publications:
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Responsible Party: Norbert Weiler, Prof. Dr. Norbert Weiler, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT02644005     History of Changes
Other Study ID Numbers: AVAS
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs