Clinical trial NCT02644005: Automated Control of Mechanical Ventilation During General Anaesthesia
Official title: Automated Control of Mechanical Ventilation During General Anaesthesia - A Bicentric Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Drägerwerk AG & Co. KGaA
First posted: 2015-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients scheduled for elective surgery in general anesthesia.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Frequency of adverse events.
timeFrame: During artificial ventilation with SVC (up to 8 hours).
Secondary outcomes:
measure: Frequency of normoventilated, hypoventilated and hyperventilated patients.
timeFrame: During artificial ventilation with SVC (up to 8 hours).
measure: Time period between switch from controlled ventilation to augmented ventilation and achievement of stable assisted ventilation of the patient.
timeFrame: During artificial ventilation with SVC (up to 8 hours).
measure: Proportion of time within the target zones for tidal volume and PetCO2 as individually set up for each patient by the user.
timeFrame: During artificial ventilation with SVC (up to 8 hours).
measure: Frequency of alarms.
timeFrame: During artificial ventilation with SVC (up to 8 hours).
measure: Frequency distribution of tidal volume (ml/kg predicted body weight).
timeFrame: During artificial ventilation with SVC (up to 8 hours).
measure: Frequency distribution of inspiratory pressure (mbar).
timeFrame: During artificial ventilation with SVC (up to 8 hours).
measure: Frequency distribution of inspiration time (s).
timeFrame: During artificial ventilation with SVC (up to 8 hours).
measure: Frequency distribution of expiration time (s).
timeFrame: During artificial ventilation with SVC (up to 8 hours).
measure: Frequency distribution of PetCO2 (mmHg).
timeFrame: During artificial ventilation with SVC (up to 8 hours).
measure: Number of re-intubations.
timeFrame: During artificial ventilation with SVC (up to 8 hours).
Other outcomes:
Locations:
city: St. Pölten
country: Austria
facility: University Hospital St. Pölten, Department of Anesthesiology and Intensive Care Medicine
city: Kiel
country: Germany
facility: University Medical Center Schleswig-Holstein, Campus Kiel, Department of Anesthesiology and Intensive Care Medicine
Study officials:
affiliation: University Medical Center Schleswig-Holstein, Campus Kiel, Germany, Department of Anesthesiology and Intensive Care Medicine
name: Norbert Weiler, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital St. Pölten, Austria, Department of Anesthesiology and Intensive Care Medicine
name: Christoph Hörmann, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.